Feel Proud to be Clini-indian - Chance to be a part of India's No.1 Training organization - Clini-India BANGALORE

<div dir="ltr" style="text-align: left;" trbidi="on"> <br /> <div style="text-align: center;"> <img alt="" border="0" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEgcBh3_E6KeALFapISieRuGFr0ckRJxkNwEHetIpyrPb4mQvGgZZ5uxEStp62fFCKWTNytFcVJ4Vx_HSXq7x85FZyKYUk8_dIZQYtFVE4ALkRriPYiJqc9EWnz6jkWmeCZlwuDAJ9iTJBgVI6ZUPBP9E_pPvhPWYRvBnRdiUaiEohl68RzH99kALIPLofHWY4XL8kkDNj10mw=s0-d-e1-ft" style="-webkit-text-stroke-width: 0px; background-color: #f4f4f4; border: 0px; color: #505050; font-family: Helvetica; font-size: 20px; font-style: normal; font-variant: normal; font-weight: bold; letter-spacing: normal; line-height: 20px; margin: 0px; max-width: 600px; orphans: auto; outline: none; padding: 0px; text-align: center; text-decoration: none; text-indent: 0px; text-transform: none; white-space: normal; widows: 1; word-spacing: 0px;" /> </div> <div style="text-align: center;"> <br /></div> <div style="text-align: center;"> <img alt="" border="0" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEhOEX1qTPufWA4KigcQ_cC_UQEdMKszEYVrdXa-VSZ9JsyPSlxMlKS7vc6fYgbZkpZS48ofxqnm7p4ZGgqGFYsy3jRRjGCQRnOqm5oQ9zFN0v8FhiE49XSjCFt_sbxx_z3Tk5aabLpgg0ccYE9TnFIOf-2f39BD_U4YdDHk3VVIBpHYD9vIZaYqJvQPvarHxIoUwEetk0UBwU_4ZxNiWsL09ElHrq6-Jw=s0-d-e1-ft" style="background-color: #f4f4f4; border: 0px none; color: #505050; font-family: Helvetica; font-size: 20px; font-style: normal; font-variant: normal; font-weight: bold; letter-spacing: normal; line-height: 20px; margin: 0px; max-width: 520px; outline: medium none; padding: 0px; text-align: center; text-decoration: none; text-indent: 0px; text-transform: none; white-space: normal; widows: 1; word-spacing: 0px;" width="520" /> </div> <div style="text-align: center;"> <br /></div> <table border="0" cellpadding="0" cellspacing="0" style="-webkit-text-stroke-width: 0px; background-color: #abdef3; border: 0px; color: #222222; font-family: arial, sans-serif; font-size: small; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: normal; orphans: auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 1; width: 600px; word-spacing: 0px;"><tbody> <tr><td align="center" style="border-collapse: collapse; font-family: arial, sans-serif; margin: 0px;" valign="top"><table border="0" cellpadding="0" cellspacing="0" style="background-color: #f4f4f4; border-bottom-color: rgb(204, 204, 204); border-bottom-style: solid; border-bottom-width: 1px; border-top-color: rgb(255, 255, 255); border-top-style: solid; border-top-width: 1px; width: 600px;"><tbody> <tr><td align="center" style="border-collapse: collapse; font-family: arial, sans-serif; margin: 0px;" valign="top"><table border="0" cellpadding="0" cellspacing="0" style="width: 100%px;"><tbody> <tr><td align="center" style="border-collapse: collapse; font-family: arial, sans-serif; margin: 0px; padding: 20px;" valign="top"><table border="0" cellpadding="0" cellspacing="0" style="width: 560px;"><tbody> <tr><td align="center" rowspan="2" style="background-color: #0e76bc; border-collapse: collapse; font-family: Georgia; font-size: 20px; line-height: 30px; margin: 0px; padding: 20px; text-align: center; text-decoration: none;" width="540"><span style="color: white;">CLINI INDIA- </span><br /> <div style="display: inline;"> <span style="color: white;">​</span><br /> <div style="color: #20124d; display: inline; font-family: verdana, sans-serif;"> ​</div> <div style="display: inline; font-family: verdana, sans-serif;"> <span style="color: white;">Bangalore​</span></div> <span style="color: white;"> ​</span></div> <span style="color: white;"><span class="Apple-converted-space"> </span>Inviting Pharma/ Life Science Graduates.</span><br /> <h3 style="display: block; font-family: Georgia; font-size: 18px; font-style: normal; font-weight: normal; letter-spacing: normal; line-height: 18px; margin: 0px 0px 10px; text-align: center;"> <span style="color: white;">Admission open for Advanced Program in Clinical Research &amp; Management.</span></h3> </td><td height="10" style="border-collapse: collapse; font-family: arial, sans-serif; margin: 0px;" width="10"><img height="10" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEi1-jcrdYVlPSpD-dXRL9rQ8Bsm9ueHrQ1pBByYdKveeIm5qjzB7TzS3g2g895jpeSP1mCEmEYfC9Lk_SpHIdD-i5C5nPw04Ail84ubn_CNHPWBPFUbVAxhqg7_YvN1ccxDweg3IKFfnAxdnhxbDTP993HO-Uc-VY6mFX0bNRLRp8oqeU399r8i=s0-d-e1-ft" style="border: 0px; display: block; line-height: 13px; margin: 0px; min-height: 10px !important; outline: none; padding: 0px; text-decoration: none;" width="10" /></td></tr> <tr><td style="background-color: #505050; border-collapse: collapse; font-family: arial, sans-serif; margin: 0px;" width="10">  </td><td style="background-color: #505050; border-collapse: collapse; font-family: arial, sans-serif; margin: 0px;" width="10"><br /></td></tr> <tr><td colspan="3" style="border-collapse: collapse; font-family: arial, sans-serif; margin: 0px;"><table border="0" cellpadding="0" cellspacing="0" style="width: 560px;"><tbody> <tr><td height="10" style="background-color: #505050; border-collapse: collapse; font-family: arial, sans-serif; margin: 0px;" width="20"><img height="6" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEi1-jcrdYVlPSpD-dXRL9rQ8Bsm9ueHrQ1pBByYdKveeIm5qjzB7TzS3g2g895jpeSP1mCEmEYfC9Lk_SpHIdD-i5C5nPw04Ail84ubn_CNHPWBPFUbVAxhqg7_YvN1ccxDweg3IKFfnAxdnhxbDTP993HO-Uc-VY6mFX0bNRLRp8oqeU399r8i=s0-d-e1-ft" style="border: 0px; display: block; line-height: 13px; margin: 0px; min-height: 6px !important; outline: none; padding: 0px; text-decoration: none;" width="14" /></td><td height="10" style="border-collapse: collapse; font-family: arial, sans-serif; margin: 0px;" width="500"><img height="6" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEi1-jcrdYVlPSpD-dXRL9rQ8Bsm9ueHrQ1pBByYdKveeIm5qjzB7TzS3g2g895jpeSP1mCEmEYfC9Lk_SpHIdD-i5C5nPw04Ail84ubn_CNHPWBPFUbVAxhqg7_YvN1ccxDweg3IKFfnAxdnhxbDTP993HO-Uc-VY6mFX0bNRLRp8oqeU399r8i=s0-d-e1-ft" style="border: 0px; display: block; line-height: 13px; margin: 0px; min-height: 6px !important; outline: none; padding: 0px; text-decoration: none;" width="132" /></td><td height="10" style="background-color: #505050; border-collapse: collapse; font-family: arial, sans-serif; margin: 0px;" width="20"><img height="6" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEi1-jcrdYVlPSpD-dXRL9rQ8Bsm9ueHrQ1pBByYdKveeIm5qjzB7TzS3g2g895jpeSP1mCEmEYfC9Lk_SpHIdD-i5C5nPw04Ail84ubn_CNHPWBPFUbVAxhqg7_YvN1ccxDweg3IKFfnAxdnhxbDTP993HO-Uc-VY6mFX0bNRLRp8oqeU399r8i=s0-d-e1-ft" style="border: 0px; display: block; line-height: 13px; margin: 0px; min-height: 6px !important; outline: none; padding: 0px; text-decoration: none;" width="14" /></td></tr> </tbody></table> </td></tr> </tbody></table> </td></tr> </tbody></table> </td></tr> </tbody></table> </td></tr> <tr><td align="center" style="border-collapse: collapse; font-family: arial, sans-serif; margin: 0px;" valign="top"><table border="0" cellpadding="0" cellspacing="0" style="background-color: #f4f4f4; border-bottom-color: rgb(204, 204, 204); border-bottom-style: solid; border-bottom-width: 1px; border-top-color: rgb(255, 255, 255); border-top-style: solid; border-top-width: 1px; width: 600px;"><tbody> <tr><td align="center" style="border-collapse: collapse; font-family: arial, sans-serif; margin: 0px;" valign="top"><table border="0" cellpadding="20" cellspacing="0" style="width: 100%px;"><tbody> <tr><td align="center" style="border-collapse: collapse; border-right-color: rgb(221, 221, 221); border-right-style: solid; border-right-width: 1px; font-family: arial, sans-serif; margin: 0px;" valign="top"><table border="0" cellpadding="0" cellspacing="0" style="width: 100%px;"><tbody> <tr><td style="border-collapse: collapse; font-family: Helvetica; line-height: 19.5px; margin: 0px; text-align: left;" valign="top"><h2 style="color: #0e76bc; display: block; font-family: Georgia; font-size: 26px; font-style: normal; font-weight: normal; letter-spacing: normal; line-height: 26px; margin: 0px 0px 10px; text-align: left;"> About CLINI INDIA</h2> <b style="color: #505050; font-size: 15px;">​Welcome</b><br /> <span style="color: black;"><b><span style="font-size: 15px;">CLINI INDIA is India's Premier Clinical Research Institute, awarded for Best Placements amongst Clinical Research Institutes &amp; Best Clinical Research Institute by Brands Academy.</span><br /><span style="font-size: 15px;">Students from CLINI INDIA are working with leading CROs, Pharma and IT Companies.</span><br /><span style="font-size: 15px;">You can also plan your career with us -</span></b></span><br /> <span style="color: #505050; font-size: 15px;"><span style="line-height: 15px; width: 417px;"><img align="none" height="121" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEj1FtVAPOUdl9ycg15F8YcEgrEAUOuUjutHikoQOusSloPI9SNoZEXN9wh07ZxUjfu9WrTMPWSV1H46ivXC5hh1O_akCmWlLCjPOiOPuPqZR78ulL_ulLx2EpJMGY8Nj_njpvXpX-qjalKchm7UGoyeAsKL1hNkJ941W7br_bURovkKmPjyV_dcq9XEmBLzatiwNs4-kfd4zWrdFRlS4L4cIRY7NnwxvQ=s0-d-e1-ft" style="border: 0px; display: inline; line-height: 15px; margin: 0px; max-width: 325px !important; min-height: 121px; outline: none; text-decoration: none; width: 417px;" width="417" /></span></span><br /> <span style="color: #505050; font-size: 15px;">​</span><br /> <h2 style="color: #0e76bc; display: block; font-family: Georgia; font-size: 26px; font-style: normal; font-weight: normal; letter-spacing: normal; line-height: 26px; margin: 0px 0px 10px; text-align: left;"> Program details</h2> <b style="color: #505050; font-size: 15px;">Advanced Program in Clinical Research &amp; Management<br /><br />Modules Covers:</b><br /> <ul style="font-size: 15px;"> <li><b><span style="color: blue;">Clinical Trial Management</span></b></li> <li><b><span style="color: blue;">Clinical Data Management</span></b></li> <li><b><span style="color: blue;">Pharmacovigilance</span></b></li> <li><b><span style="color: blue;">Medical Writing</span></b></li> </ul> <h2 style="color: #0e76bc; display: block; font-family: Georgia; font-size: 26px; font-style: normal; font-weight: normal; letter-spacing: normal; line-height: 26px; margin: 0px 0px 10px; text-align: left;"> <b style="color: navy; font-family: Helvetica; font-size: 15px; line-height: 22.5px;">CLINI INDIA-Advantage</b></h2> <ul style="font-size: 15px;"> <li><b><span style="color: black;">Award Winning Institute for Placements</span></b></li> <li><b><span style="color: black;">Expert faculties from Leading CROs</span></b></li> <li><b><span style="color: black;">Referral support for Fresher's Openings</span></b></li> <li><b><span style="color: black;">Practical Training on Pharmacovigilance and CDM</span></b></li> </ul> <br /> <span style="color: #505050; font-size: 15px;"><span style="line-height: 15px;"><img align="none" height="168" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEgJ95g4tJCvoTL_NpNJejVRmccSQHUFgDAw1nQOZkmRAgYZ61epkGV5W1Akn-aMjKa9RSfJz4KjReHZEI1rsIMOh8J1KyI7smvcdULCnjAymS_bUd56afkiFUZKpiuRQehQonXbdDi8nEFIe__uYKQKQ1BomWHIFa9EN_-GcsCQyusqqzmDKbFq_OsDgwvV1KubnZ0MBpWsRzwxeo1BArpONvuJzVJM5Q=s0-d-e1-ft" style="border: 0px; display: inline; line-height: 15px; margin: 0px; max-width: 325px !important; min-height: 168px; outline: none; text-decoration: none; width: 300px;" width="300" /></span></span><br /> <br /> <br /> <span style="color: #505050; font-size: 15px;">​<b>Contact us</b></span><br /> <div style="color: #20124d; display: inline; font-family: verdana, sans-serif;"> <span style="color: #505050; font-size: 15px;"><b>​-​</b></span></div> <span style="color: #505050; font-size: 15px;"><b> </b></span> <br /> <h2 style="color: #0e76bc; display: block; font-family: Georgia; font-size: 26px; font-style: normal; font-weight: normal; letter-spacing: normal; line-height: 26px; margin: 0px 0px 10px; text-align: left;"> <span style="font-size: 14px;">Program Co-ordinator</span></h2> <div style="display: inline; font-size: 15px;"> <div style="display: inline; font-family: verdana, sans-serif;"> <span style="color: #20124d;">​</span><b><span style="color: #0b5394;">ABHAY SINGH</span><i><br /><span style="color: #20124d;">​</span></i></b></div> <b style="color: #0b5394;"><i>​</i></b><br /> <div style="color: #20124d; display: inline; font-family: verdana, sans-serif;"> <b style="color: #0b5394;"><i>​</i></b></div> <b style="color: #0b5394;"><i> </i></b> <br /> <div style="background-color: white; display: inline; font-family: arial, sans-serif; font-size: 12.8000001907349px; line-height: normal;"> <span style="color: #0b5394;"><span style="font-family: trebuchet ms, sans-serif; font-size: medium;"><b>CLINI INDIA EPIP ZONE 104,<br />LEVEL 2, PRESTIGE OMEGA,<br />WHITEFIELD,BANGALORE<br />KARNATAKA-560066</b></span></span></div> <span style="color: #0b5394;"> <b style="background-color: white; font-family: 'trebuchet ms', sans-serif; font-size: large; line-height: normal;">Contact no.<span class="Apple-converted-space"> </span></b></span><br /> <div style="display: inline; font-family: verdana, sans-serif;"> <span style="color: #0b5394;"><b style="background-color: white; font-family: 'trebuchet ms', sans-serif; font-size: large; line-height: normal;">​0​</b></span></div> <span style="color: #0b5394;"><b style="background-color: white; font-family: 'trebuchet ms', sans-serif; font-size: large; line-height: normal;"> </b></span> <br /> <div style="display: inline; font-family: verdana, sans-serif;"> <span style="color: #0b5394;"><b style="background-color: white; font-family: 'trebuchet ms', sans-serif; font-size: large; line-height: normal;"><a href="tel:9289870004" style="color: #1155cc;" target="_blank" value="+919289870004">9289870004</a>​</b></span></div> <span style="color: #0b5394;"><b style="background-color: white; font-family: 'trebuchet ms', sans-serif; font-size: large; line-height: normal;"> /</b></span><br /> <div style="display: inline; font-family: verdana, sans-serif;"> <span style="color: #0b5394;"><b style="background-color: white; font-family: 'trebuchet ms', sans-serif; font-size: large; line-height: normal;">​<a href="tel:08050040004" style="color: #1155cc;" target="_blank" value="+918050040004">08050040004</a>​</b></span><br /> <span style="color: #0b5394;"><b style="background-color: white; font-family: 'trebuchet ms', sans-serif; font-size: large; line-height: normal;"><br /></b></span></div> <span style="color: #0b5394;"><b style="background-color: white; font-family: 'trebuchet ms', sans-serif; font-size: large; line-height: normal;"> </b></span></div> <div style="font-family: arial, sans-serif;"> <br /> <b style="color: #505050;"><span style="font-size: medium;">To know more about program:</span></b></div> <div style="font-family: arial, sans-serif;"> <span style="color: #505050; font-size: medium;"><b><br /></b></span></div> <div style="font-family: arial, sans-serif;"> <b><span style="font-size: medium;">Visit - <a href="http://www.cliniindia.com/" style="color: #1155cc;" target="_blank"><span style="color: blue;">www.cliniindia.com</span></a></span></b></div> <div style="font-family: arial, sans-serif;"> <b><span style="font-size: medium;"><br /></span></b></div> <div style="font-family: arial, sans-serif;"> <b><span style="font-size: medium;">To know about our placement record please visit-</span></b></div> <div style="font-family: arial, sans-serif;"> <b><span style="color: blue; font-size: medium;"><a href="http://www.cliniindia.weebly.com/" style="color: #1155cc;" target="_blank">www.cliniindia.weebly.com</a></span></b><br /> <span style="color: #505050;"><span style="font-size: 15px;"><b><br /></b></span></span><span style="color: #505050; font-size: 15px;"> <a href="https://docs.google.com/forms/d/1KsCI_hqpaqRsLwCXXYogXOa0o90iHrgWyodKO450Fr4/viewform" style="color: #1155cc;" target="_blank"><img alt="Apply here" height="87" src="https://mail.google.com/mail/u/0/?ui=2&ik=7377f92c5c&view=fimg&th=14c16d5845df41c1&attid=0.1&disp=emb&realattid=ii_i78leguu1_14c16d387e510f6e&attbid=ANGjdJ_Cl7tfkHmoEsthN_w2PxrNtGynPHc0AXajMZ6Pe9jBOE1JMdPMD_06Qv3wN8s2EHOCrl1RA0rqf8lb1e3psOifdEjv-H0X-tZOvwnmyoKZSQT741lc20bhc-U&sz=w600-h174&ats=1426478568424&rm=14c16d5845df41c1&zw&atsh=1" width="300" /></a><br />​</span></div> </td></tr> </tbody></table> </td><td style="background-color: #f4f4f4; border-collapse: collapse; border-left-color: rgb(255, 255, 255); border-left-style: solid; border-left-width: 1px; font-family: arial, sans-serif; margin: 0px;" valign="top" width="160"><table border="0" cellpadding="0" cellspacing="0" style="width: 160px;"><tbody> <tr><td height="6" style="border-collapse: collapse; font-family: arial, sans-serif; margin: 0px;" width="6"><img height="6" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEi1-jcrdYVlPSpD-dXRL9rQ8Bsm9ueHrQ1pBByYdKveeIm5qjzB7TzS3g2g895jpeSP1mCEmEYfC9Lk_SpHIdD-i5C5nPw04Ail84ubn_CNHPWBPFUbVAxhqg7_YvN1ccxDweg3IKFfnAxdnhxbDTP993HO-Uc-VY6mFX0bNRLRp8oqeU399r8i=s0-d-e1-ft" style="border: 0px; display: block; line-height: 13px; margin: 0px; min-height: 6px !important; outline: none; padding: 0px; text-decoration: none;" width="6" /></td><td align="center" rowspan="2" style="background-color: #0e76bc; border-collapse: collapse; color: white; font-family: Georgia; font-size: 13px; line-height: 19.5px; margin: 0px; padding: 10px; text-align: center; text-decoration: none;" width="126">More Details</td><td height="6" style="border-collapse: collapse; font-family: arial, sans-serif; margin: 0px;" width="6"><img height="6" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEi1-jcrdYVlPSpD-dXRL9rQ8Bsm9ueHrQ1pBByYdKveeIm5qjzB7TzS3g2g895jpeSP1mCEmEYfC9Lk_SpHIdD-i5C5nPw04Ail84ubn_CNHPWBPFUbVAxhqg7_YvN1ccxDweg3IKFfnAxdnhxbDTP993HO-Uc-VY6mFX0bNRLRp8oqeU399r8i=s0-d-e1-ft" style="border: 0px; display: block; line-height: 13px; margin: 0px; min-height: 6px !important; outline: none; padding: 0px; text-decoration: none;" width="6" /></td></tr> <tr><td style="background-color: #505050; border-collapse: collapse; font-family: arial, sans-serif; margin: 0px;" width="6"><br /></td><td style="background-color: #505050; border-collapse: collapse; font-family: arial, sans-serif; margin: 0px;" width="6"><br /></td></tr> <tr><td colspan="3" style="border-collapse: collapse; font-family: arial, sans-serif; margin: 0px; padding-bottom: 15px;"><table border="0" cellpadding="0" cellspacing="0" style="width: 160px;"><tbody> <tr><td height="6" style="background-color: #505050; border-collapse: collapse; font-family: arial, sans-serif; margin: 0px;" width="14"><img height="6" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEi1-jcrdYVlPSpD-dXRL9rQ8Bsm9ueHrQ1pBByYdKveeIm5qjzB7TzS3g2g895jpeSP1mCEmEYfC9Lk_SpHIdD-i5C5nPw04Ail84ubn_CNHPWBPFUbVAxhqg7_YvN1ccxDweg3IKFfnAxdnhxbDTP993HO-Uc-VY6mFX0bNRLRp8oqeU399r8i=s0-d-e1-ft" style="border: 0px; display: block; line-height: 13px; margin: 0px; min-height: 6px !important; outline: none; padding: 0px; text-decoration: none;" width="14" /></td><td height="6" style="border-collapse: collapse; font-family: arial, sans-serif; margin: 0px;" width="132"><img height="6" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEi1-jcrdYVlPSpD-dXRL9rQ8Bsm9ueHrQ1pBByYdKveeIm5qjzB7TzS3g2g895jpeSP1mCEmEYfC9Lk_SpHIdD-i5C5nPw04Ail84ubn_CNHPWBPFUbVAxhqg7_YvN1ccxDweg3IKFfnAxdnhxbDTP993HO-Uc-VY6mFX0bNRLRp8oqeU399r8i=s0-d-e1-ft" style="border: 0px; display: block; line-height: 13px; margin: 0px; min-height: 6px !important; outline: none; padding: 0px; text-decoration: none;" width="132" /></td><td height="6" style="background-color: #505050; border-collapse: collapse; font-family: arial, sans-serif; margin: 0px;" width="14"><img height="6" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEi1-jcrdYVlPSpD-dXRL9rQ8Bsm9ueHrQ1pBByYdKveeIm5qjzB7TzS3g2g895jpeSP1mCEmEYfC9Lk_SpHIdD-i5C5nPw04Ail84ubn_CNHPWBPFUbVAxhqg7_YvN1ccxDweg3IKFfnAxdnhxbDTP993HO-Uc-VY6mFX0bNRLRp8oqeU399r8i=s0-d-e1-ft" style="border: 0px; display: block; line-height: 13px; margin: 0px; min-height: 6px !important; outline: none; padding: 0px; text-decoration: none;" width="14" /></td></tr> </tbody></table> </td></tr> </tbody></table> <table border="0" cellpadding="0" cellspacing="0" style="width: 160px;"><tbody> <tr><td style="border-collapse: collapse; color: #707070; font-family: Helvetica; font-size: 13px; line-height: 19.5px; margin: 0px; padding-bottom: 20px; text-align: left;" valign="top"><h4 style="color: #0e76bc; display: block; font-family: Georgia; font-size: 13px; font-style: normal; font-weight: normal; letter-spacing: normal; line-height: 13px; margin: 0px 0px 10px; text-align: left;"> <b>Eligibiligy:</b></h4> <img align="none" height="51" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEhErLsEQZUJctrnKVJGh8nTltEQfSIUpO-RkRZyqoG7vjNO-TKHytKp6xjPxLirw6fZrNKiBHLCXlBLU0ghsrnEs39XBS1PnddLw3WS35eC6wbtCi6jBt6FsejP4Ns18ViU5CV_TgKJHmZhsTaXVo1Xea9p58Lx5OUzHSbIeKSck89n0BlqlG5ADhr5E3Z486CnnccUHwex95bLLbZRSyhSZSiWiMHtRA=s0-d-e1-ft" style="border: 0px; display: inline; line-height: 13px; margin: 0px; max-width: 160px !important; min-height: 51px; outline: none; text-decoration: none; width: 120px;" width="120" /><br /> <br /> <b>B.Pharm/ M.Pharm Candidates<br />B.Tech/ M. Tech in Life Sciences<br />Life Science and Medical Grad.<br />Staff Involved in Clinical Trials<br />Nursing &amp; Physiotherapy Grad.</b><br /> <b>Principal Investigators from hospitals</b></td></tr> </tbody></table> <table border="0" cellpadding="0" cellspacing="0" style="width: 160px;"><tbody> <tr><td style="border-collapse: collapse; font-family: Helvetica; line-height: 19.5px; margin: 0px; padding-bottom: 20px; text-align: left;" valign="top"><h4 style="color: #0e76bc; display: block; font-family: Georgia; font-style: normal; font-weight: normal; letter-spacing: normal; line-height: 13px; margin: 0px 0px 10px; text-align: left;"> <b><div style="display: inline; font-family: verdana, sans-serif;"> ​<span style="color: red;">BATCH  STARTING         FROM - 5th April</span><br /> <div style="color: #0b5394; display: inline;"> <span style="color: red;">​ ​</span></div> <span style="color: red;"> 2015</span></div> </b></h4> <h4 style="color: #0e76bc; display: block; font-family: Georgia; font-size: 13px; font-style: normal; font-weight: normal; letter-spacing: normal; line-height: 13px; margin: 0px 0px 10px; text-align: left;"> </h4> <a href="https://www.facebook.com/clinicalresearchjobsopenings" style="color: #1155cc;" target="_blank"><img alt=" For job click here" height="67" src="https://mail.google.com/mail/u/0/?ui=2&ik=7377f92c5c&view=fimg&th=14c16d5845df41c1&attid=0.2&disp=emb&realattid=ii_i78l7s650_14c16cec4bf3a844&attbid=ANGjdJ9R1I11qpoCD_TnPKJtGODEJ1rFhsSfDfE4-ob163cPYKBV8SfegX5pzUUhLYJLBSIPw-EpzF52ux_TDdCVZAR12Rg3w8Y9_Bw01wny6fKIv5f40GgRQ7hkg0c&sz=w352-h134&ats=1426478568428&rm=14c16d5845df41c1&zw&atsh=1" style="margin-right: 0px;" width="176" /></a><br /> ​<br /> <h4 style="color: #0e76bc; display: block; font-family: Georgia; font-size: 13px; font-style: normal; font-weight: normal; letter-spacing: normal; line-height: 13px; margin: 0px 0px 10px; text-align: left;"> <b style="line-height: 13px;"><br /></b></h4> <h4 style="color: #0e76bc; display: block; font-family: Georgia; font-size: 13px; font-style: normal; font-weight: normal; letter-spacing: normal; line-height: 13px; margin: 0px 0px 10px; text-align: left;"> <b style="line-height: 13px;">Training Advantage</b></h4> <span style="color: #707070; font-size: 13px;">​<span style="line-height: 13px;"><img align="none" height="75" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEhVFmpZ-65RC4ssU6S8N-9wLbZDqUHuSqa9hkeCjzSRhj_E-hiVdaWbrTW-iLBy3v_km6aFD7Yjz2bCpz3qX7FLN__6OnqcqzHYLtNAVPRv0i7d_WoOOlCTjBrvyAWfhJm71gc_Zv5z7Wr55dnCFVV7Ka63Ng72U-TatzaYNAAh-rlMYMv2oYh-xbfkx9xRoEEYQk6iZtd-nC8EbXcY5-_F0jmg9vyBBA=s0-d-e1-ft" style="border: 0px; display: inline; line-height: 13px; margin: 0px; max-width: 160px !important; min-height: 75px; outline: none; text-decoration: none; width: 100px;" width="100" /></span></span><br /> <span style="color: blue; font-size: 13px;"><b>Industry Recognized Course<br />Placement assistance<br />Easy &amp; any time any where access</b></span></td></tr> </tbody></table> <table border="0" cellpadding="0" cellspacing="0" style="width: 160px;"><tbody> <tr><td style="border-collapse: collapse; font-family: arial, sans-serif; margin: 0px; padding-bottom: 20px; text-align: left;" valign="top"><h4 style="color: #0e76bc; display: block; font-family: Georgia; font-size: 13px; font-style: normal; font-weight: normal; letter-spacing: normal; line-height: 13px; margin: 0px 0px 10px; text-align: left;"> <b>Program Features</b></h4> <span style="color: #707070; font-family: Helvetica;"><span style="line-height: 13px;"><img align="none" height="128" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEibRLlPgCWu4tJAfWPtmBhMFwWhogcOHpUtddUJ8tj_u2DZ7ZiS1YS0_z1S9DDdrndsIymQkfSjsmcZVhMSWyc6Cn2OhGtBCXEdxemDYg9C8WLehtoCk2PJWbiQh3Dg0lnZv6H61CXixW7B2WTlqRqqmYw6O5ExvXjeAzQ7QbcXLPMVB27N0zrjBN8547XGXjM1dwExcOHKiIlclvs-p64NRX-AbmSupA=s0-d-e1-ft" style="border: 0px; display: inline; line-height: 13px; margin: 0px; max-width: 160px !important; min-height: 128px; outline: none; text-decoration: none; width: 128px;" width="128" /></span></span><br /> <h4 style="display: block; margin: 0px 0px 10px; text-align: left;"> <i><span style="color: blue;"><span style="font-family: Georgia; font-size: 13px; line-height: 13px;">Free Study Material available.</span><br /><span style="font-family: Georgia;"><span style="line-height: 13px;"><br /></span></span><span style="font-family: Georgia; line-height: 13px;">All Visiting Faculty from Industry.</span></span></i></h4> <h4 style="display: block; margin: 0px 0px 10px; text-align: left;"> <i><span style="color: blue;"><span style="font-family: Helvetica; line-height: 19.5px;">Placement Support</span><br /><span style="font-family: Helvetica; line-height: 19.5px;">Interview Updates</span></span></i></h4> </td></tr> </tbody></table> <table border="0" cellpadding="0" cellspacing="0" style="width: 160px;"><tbody> <tr><td style="border-collapse: collapse; font-family: Helvetica; line-height: 19.5px; margin: 0px; padding-bottom: 20px; text-align: left;" valign="top"><h3 style="display: block; font-family: Georgia; font-size: 18px; font-style: normal; font-weight: normal; letter-spacing: normal; line-height: 18px; margin: 0px 0px 10px; text-align: left;"> <span style="font-family: 'lucida sans unicode', 'lucida grande', sans-serif;"><b><span style="color: #274e13;">Call Now:</span></b></span></h3> <span style="color: #707070; font-size: 13px;"><span style="line-height: 13px;"><img align="none" height="128" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEh9YKyDxfkieQ5ADfHdPnWwuGkdvcXXMtUbjnqTPtZx2un1_hPuXtLNVmDSma_g4aeqZ8RGm_ObOqfWFRW-AD7AM7N8u5eOPhA5TLljpWkojN3b9kuw6ESKEw8JyN24w7jmQo9QhdVlBzjrBCI-m2xtG6ZWNQu4No8Qjahb4N3QkAr6Xb4oe7FqIpzAqQH2xBH3D_LhqoSO3YEGH9VU1w0hzBXs1-A1dg=s0-d-e1-ft" style="border: 0px; display: inline; line-height: 13px; margin: 0px; max-width: 160px !important; min-height: 128px; outline: none; text-decoration: none; width: 128px;" width="128" /></span></span><br /> <h3 style="color: #231f20; display: block; font-family: Georgia; font-style: normal; letter-spacing: normal; line-height: 15.2100009918213px; margin: 0px 0px 10px; text-align: left;"> <div style="color: #0b5394; display: inline;"> <span style="font-size: 18px; font-weight: normal;">​</span><br /> <div style="color: #20124d; display: inline; font-family: verdana, sans-serif;"> <span style="font-size: 18px;">​</span><span style="font-size: medium;"><a href="tel:9289870004" style="color: #1155cc;" target="_blank" value="+919289870004">9289870004</a></span></div> <div style="color: #20124d; display: inline; font-family: verdana, sans-serif;"> <span style="font-size: medium;">​805004000</span></div> </div> <span style="color: #20124d; font-family: verdana, sans-serif; line-height: 22.8150005340576px;"><span style="font-size: medium;">​<div style="color: #20124d; display: inline; font-family: verdana, sans-serif;"> ​4</div> </span></span></h3> <br /></td></tr> </tbody></table> </td></tr> </tbody></table> </td></tr> </tbody></table> </td></tr> </tbody></table> <div style="text-align: center;"> <br /></div> <div style="text-align: center;"> <img align="none" height="282" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEhJniGfnaLwiOUgTwQn_vEgyHzRC-GR-QpQE2cSxLvD4HIsHEMtw0ycKreu9sIxmAlz4_IqLxL5myOi1KtQFVFwcAmTROBfjaKc1HPcF5vjw4UrlzEOiNh5r3hSU-PlqFF-X9AdeNYPsJkk0kKdY1lfOn-cpm5wzE57M_4hVLFg6VQzntJf4u81QJiY54m-2sH1b0vixU2eACeZKVWUYcJAp2cN1PMVGw=s0-d-e1-ft" style="-webkit-text-stroke-width: 0px; 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Feel Proud to be Clini-indian - Chance to be a part of India's No.1 Training organization - Clini-India BANGALORE

    CLINI INDIA-  ​ ​ Bangalore​ ​   Inviting Pharma/ Life Science Graduates. Admission open for Advanced Program i...

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Quality Assurance : Interview Questions -Very useful for Biotech/Pharmacy Graduates/Post graduates "D7"

<div dir="ltr" style="text-align: left;" trbidi="on"> <br /> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>1. What is an SOP ?</i></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">A Standard Operating Procedure (SOP) is a certain type of document that describes in a step-bystep outline form how to perform a particular task or operation. Everyone in a company must follow the same procedures to assure that tasks are performed consistently and correctly. Most companies have a wide variety of SOPs that describe how to do different tasks. In many companies technicians and operators are trained in how to follow individual SOPs and their training record specifies which SOPs they are trained on and are authorized to use.<o:p></o:p></span></span><br /><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>2. What is 21 CFR part 11 ?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.<o:p></o:p></span></span><br /><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>3. What are user requirements ?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">User Requirements Specification describes what users require from the System. User<br />requirement specifications are written early in the validation process, typically before the system is created. It is written by the System Owner and End Users, with input from Quality Assurance. Requirements outlined in the URS are usually tested in the Performance Qualification. User Requirements Specifications are not intended to be a technical document; readers with only a general knowledge of the system should be able to understand the requirements outlined in the URS.<o:p></o:p></span></span><br /><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>4. What is a validation plan ?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Validation Plans define the scope and goals of a validation project. Validation plans are written before a validation project and are specific to a single validation project. Validation Plans can include:<br />Deliverables (Documents) to be generated during the validation process Resources/Departments/Personnel to participate in the validation project<br />Time-Line for completing the validation project.<o:p></o:p></span></span><br /><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>5. What is an IQ document ?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Installation Qualifications are a collection of test cases used to verify the proper installation of a System. The requirement to properly install the system was defined in the Design Specification. Installation Qualifications must be performed before completing Operational Qualification or Performance Qualification.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>6. What is an OQ Document ?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Operational Qualifications are a collection of test cases used to verify the proper functioning of a System. The operational qualification tests requirements defined in the Functional Requirements. Operational Qualifications are usually performed before the system is released for use.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>7. What is a PQ Document ?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Performance Qualifications are a collection of test cases used to verify that a System performs as expected under simulated real-world conditions. The performance qualification tests requirements that were defined in the User Requirement Specification (or possibly the Functional Requirements). Due to the nature of performance qualifications, these tests are sometime conducted with power users as the system is being released.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>8. What is a Validation Summary Report ?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Validation Summary Reports provide an overview of the entire validation project. When regulatory auditors review validation projects, they typically begin by reviewing the summary report. The validation summary report should include: A description of the validation project All test cases performed, including if those test cases passed without issue. All deviations reported, including how those deviations were resolved<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>9. What is a Change Request ?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Change Control is a general term describing the process of managing how changes are introduced into a controlled System. In validation, this means how changes are made to the validated system. Change control is required to demonstrate to regulatory authorities that validated systems remain under control after system changes. Change Control systems are a favorite target of regulatory auditors because they vividly demonstrate an organization capacity to control its systems.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>10. Why water for pharmaceutical use is always kept in close loop in continuous circulation ?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Water is a best medium for many microorganisms, microorganism can be a highly pathogenic which causes serious diseases(many diseases are water born), these pathogens infect after consumption of contaminated water, microorganisms tend to settle on a surface if water is allowed to stand in a stagnant position for few hours, these settled microorganism form a film over the surface of vessel and piping, such film formed by microorganisms is also called as biofilm, biofilms are very difficult of remove, once a biofilm is formed at a particular point then that point may form a biofilm again even after cleaning very easily as seed from this point is may not completely get removed effectively. Biofilms then can become a source of microbial contaminations; therefore purified water after collection in a distribution system is always kept in a closed loop in a continuous circulation. A continuous circulation is also not enough at some points, therefore it is aided with high temperature range from 65 °C to 80°C, a minimum temperature of 65 °C is considered a self sanitizing, but better assurance is obtained with a temperature of 80°C .<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Purified water collected should be stored in a stainless still vessel which must facilitate<br />distribution to the point of use in a closed loop of continuous circulation, tank should be made of corrosion free material of construction, and must facilitate sanitization and easy cleaning.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>11. Water for pharmaceutical use shall be free cations, anions and other impurities why ?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Water for pharmaceutical must be free from inorganic as well as organic impurities, minerals, and heavy metals. Some impurities like calcium, magnesium, ferrous are responsible for degradation of drug molecule, many cations like ferrous and calcium magnesium act as catalysts in degradation reaction of drug molecule, anions like chloride are highly active they participate in nucliophylic substitution reactions, where in they break a double bond between -C=C- in to a single bond as CL –CH-CH2- , which a reason why we observe that color dies tend to fed in presence of chlorine as most of the dies used are diazo compounds which has plenty of places for nucliophylic substitution reactions, which is also a reason why stability of drug is drastically affected in presence of cations and anions from mineral origin present in water.<o:p></o:p></span></span><br /><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>12. Water for pharmaceutical use shall be free heavy metals why ?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Heavy metals like lead and arsenic are highly cumulative neurotoxic metals, heavy metals are not eliminated out of our body easily like other drugs and molecules but heavy metals bind with proteins and tend to get accumulated in fatty tissues, nerve tissue is most likely to get damaged by heavy metals, heavy metal causes nervous tissue damage there for water must be free from heavy metals.<o:p></o:p></span></span><br /><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>13. Brazil falls under which climatic zone ?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Zone IVB (30 degree celsius and 75% relative humidity)<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="font-family: Times, 'Times New Roman', serif;"><b><span style="color: #333333;"><br /></span></b></span><span style="font-family: Times, 'Times New Roman', serif;"><b><span style="color: #333333;"><i>14. Change in the size or shape of the original container requires any stability study?</i></span></b><span style="color: #333333;"><o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Change in the size or shape of the original container may not necessitate the initiation of new<br />stability study.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>15. Forced degradation (stress testing) and accelerated stability testing are same?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Forced degradation and stress testing are not same. Stress testing is likely to be carried out on a single batch of the drug substance. The testing should include the effect of temperatures (in 10°C increments (e.g., 50°C, 60°C) above that for accelerated testing), humidity (e.g., 75 percent relative humidity or greater) where appropriate, oxidation, and photolysis on the drug substance. The testing should also evaluate the susceptibility of the drug substance to hydrolysis across a wide range of pH values when in solution or suspension. Photo stability testing should be an integral part of stress testing.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>16. According to WHO guidelines what is the storage condition of climatic zone IVa and</i><br />zone IVb?<o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Zone IV a: 30°C and 65% RH (hot and humid countries)<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Zone IV b: 30°C and 75% RH (hot and very humid countries<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i><br /></i></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>17. Countries comes under climatic zone IVb?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Brazil,Cuba,China,Brunei,Cambodia,Indonesia,Malaysia,Myanmar,Philippines,Singapore,Thailand<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>18. What is the purpose of stress testing in stability studies?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Stress testing of the drug substance can help identify the likely degradation products, which can in turn help establish the degradation pathways and the intrinsic stability of the molecule and validate the stability indicating power of the analytical procedures used. The nature of the stress testing will depend on the individual drug substance and the type of drug product involved.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>19. What is the formula for calculating number of air changes in an area?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Number of air changes/hour in an area is = Total Room Airflow In CFM x 60<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Total Volume of room in cubic feet For calculating Total Room Airflow in CFM, first calculate air flow of individual filter. Formula is given below.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Air flow (in cfm) = Avg. air velocity in feet/Minute x Effective area of filter<br />Then find Total air flow. Formula is<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Total Air flow = Sum of air flow of individual filter.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Air flow Velocity can be measured with the help of Anemometer.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>20. What is dead leg?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">A dead leg is defined as an area in a piping system where liquid can become stagnant and not be exchanged during flushing.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>21. What is the recommended bio burden limits of purified water & WFI?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Purified water has a recommended bioburden limit of 100 CFU/mL, and water for injection<br />(WFI) has a recommended bio burden limit of 10 CFU/100 mL.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>22. Brief about ICH stabilty guidelines?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Q1A- Stability testing of new drug substance & products<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Q1B- Photo stability testing of new drug substances & products<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Q1C-Stability testing of new dosage forms<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Q1D-Bracketing & Matrixing designs for testing of new drug substances and products<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Q1E-Evaluation of stability data<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Q1F-Stability data package for registration applications in climatic zone III & IV (Withdrawed)<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>23. What is significant changes in stability testing?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">1. A 5% change in assay for initial value.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">2. Any degradation products exceeds its acceptance criterion.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">3. Failure to meet acceptance criterion for appearance, physical attributes and functionality test.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">4. Failure to meet acceptance criteria for dissolution for 12 units.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>23. If leak test fail during in process checks what needs to be done?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Immediately stop packing process and check for<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">1. Sealing temperature<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">2. Verify for any possible changes like foil width, knurling etc.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">3. Check & quarantine the isolated quantity of packed goods from last passed inprocess.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">4. Collect random samples & do retest.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">5. Blisters from the leak test passed containers shall allow to go further and rest must be deblistered/ defoiled accordingly.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>24. How many Tablets shall be taken for checking friability?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">For tablets with unit mass equal or less than 650 mg, take sample of whole tablets<br />corresponding to 6.5g.For tablets with unit mass more than 650mg,take a sample of 10 whole tablets.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>25. What is the formula for calculating weight loss during friability test?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in 0in 0in 0.5in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">%Weight loss = Initial Weight - Final Weight X 100/<br />Initial Weight<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>26. What is the pass or fail criteria for friability test?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Generally the test is run for once. If any cracked, cleaved or broken tablets present in the tablet sample after tumbling, the tablets fails the test. If the results are doubtful, or weight loss is grater than the targeted value, the test should be repeated twice and the mean of the three tests determined. A mean weight loss from the three samples of not more than 1.0% is considered acceptable for most of the products.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>27. What is the standard number of rotations used for friability test?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">100 rotations<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>28. What is the fall height of the tablets in the friabilator during friability testing?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">6 inches. Tablets falls from 6 inches eight in each turn within the apparatus.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>29. Why do we check hardness during inprocess checks?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">To determine need for the pressure adjustments on the tableting machine. Hardness can affect the disintegration time. If tablet is too hard, it may not disintegrate in the required period of time. And if tablet is too soft it will not withstand handling and subsequent processing such as coating, packing etc.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>30. What are the factors which influence tablet hardness?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">1. compression force<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">2. Binder quantity (More binder more hardness)<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">3. Moisture content<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>31. Which type of tablets are exempted from Disintegration testing?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">A. Chewable Tablets<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>32. Which capsule is bigger in size - size '0' or size '1'?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">'0' size<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>33. What is the recommended temperature for checking DT of a dispersible tablet?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">25 ±10C (IP) & 15 – 250C (BP)<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>34. What is mesh aperture of DT apparatus ?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">1.8 -2.2mm (#10)<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>35. What is the pass/fail criteria for disintegration test?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">If one or two tablets/capsules fails to disintegrate completely, repeat the test on another 12 additional dosage units. The requirement is meet if not fewer than 16 out of 18 tablets/capsules tested are disintegrated completely.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i><br /></i></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>36. What is the recommended storage conditions for empty hard gelatin capsules?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">            A. 15 - 25 0C & 35 -55% RH<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>37. Which method is employed for checking “Uniformity of dosage unit”?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">A.) Content uniformity<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">B.) Weight Variation<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Weight variation is applicable for following dosage forms; Hard gelatin capsules, uncoated or film coated tablets, containing 25mg or more of a drug substance comprising 25% or more by weight<br />of dosage unit.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>38. What is the recommended upward and downward movement frequency of a basketrack assembly in a DT apparatus?<o:p></o:p></i></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">28 – 32 cycles per minute.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>39. When performing the ‘uniformity of weight’ of the dosage unit, how many tablet/capsule can deviate the established limit?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Not more than two of the individual weights can deviates from the average weight by more than the percentage given in the pharmacopeia, and none can deviates more than twice that percentage.<br />Weight Variation limits for Tablets IP/USP/BP refer current Pharmacopoeia<o:p></o:p></span></span><br /><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>40. What needs to be checked during inprocess QA checks?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">a.) Environmental Monitoring<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">b.) Measured values obtained from the process equipment (ex: temperature, RPM etc.)<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">c.) Measured values obtained from persons (ex: timmings, entries etc.)<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">d.) Process attributes (Ex: weight, hardness, friability etc.)<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>41. What precautions shall be taken while collecting inprocess samples ?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">While collecting inprocess samples, avoid contamination of the product being sampled (Don’t collect samples with bare hands) & avoid contamination of sample taken.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>42. In a tablet manufacturing facility ‘positive’ pressure is maintained in processing area or service corridors?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">In tablet manufacturing facilities, pressure gradients are maintained to avoid cross<br />contamination of products through air. Usually processing areas are maintained under positive<br />pressure with respect to service corridors.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>43. If sticking observed during tablet compression what may the probable reason for the same?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">1. If the granules are not dried properly sticking can occur.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">2. Too little or improper lubrication can also leads to sticking.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">3. Sticking can occur because of too much binder or hygroscopic granular.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="font-family: Times, 'Times New Roman', serif;"><b><span style="color: #333333;"><br /></span></b></span><span style="font-family: Times, 'Times New Roman', serif;"><b><span style="color: #333333;"><i>44. What checks shall be carried out, while calibrating DT apparatus?</i></span></b><span style="color: #333333;"><o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">While calibrating DT apparatus, following checks shall be performed.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in 0in 0in 0.75in; text-align: justify; text-indent: -0.25in;"> <span style="font-family: Times, 'Times New Roman', serif;"><span style="color: #333333;">1.<span style="line-height: normal;">     </span></span><span style="color: #333333;">Number of strokes per minute (Limit:29-32 cycles/min)<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in 0in 0in 0.75in; text-align: justify; text-indent: -0.25in;"> <span style="font-family: Times, 'Times New Roman', serif;"><span style="color: #333333;">2.<span style="line-height: normal;">     </span></span><span style="color: #333333;">Temperature by probe & standard thermometer (Limit: 37 ± 1 OC).<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt 0.75in; text-align: justify; text-indent: -0.25in;"> <span style="font-family: Times, 'Times New Roman', serif;"><span style="color: #333333;">3.<span style="line-height: normal;">     </span></span><span style="color: #333333;">Distance travelled by basket (Limit:53 -57mm)<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i><b><br /></b></i></span></span><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i><b>45. What is In process checks?</b></i><b><o:p></o:p></b></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">In process checks are checks performed during an activity, In order to monitor and, if necessary, to adjust the process to ensure that product confirms to its specification.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>46. What is the difference between disintegration and dissolution?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Disintegration is a disaggregation process, in which an oral dosage form falls apart in to smaller aggregates. (Disintegration time is the ‘break up’ time of a solid dosage form). Where as dissolution is a process by which solid substance enters in the solvent to yield a solution. It is controlled by the affinity between the solid substance and the solvent. In other word disintegration is a subset of dissolution.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>47. Why do we calibrate a qualified equipment/instrument on definite intervals?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">An equipment or instrument can ‘drift’ out of accuracy between the time of qualification and actual use. So it is recommended to calibrate and recalibrate the measuring devices and instruments on predetermined time intervals, to gain confidence on the accuracy of the data.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <span style="font-family: Times, 'Times New Roman', serif;"><b><span style="color: #333333;"><br /></span></b></span><span style="font-family: Times, 'Times New Roman', serif;"><i><b><span style="color: #333333;">48. Why do we consider three consecutive runs/batches for process validation? Why not two or four?</span></b><span style="color: #333333;"><o:p></o:p></span></i></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">The number of batches produced in the validation exercise should be sufficient to allow the<br />normal extent of variation and trends to be established and to provide sufficient data for<br />evaluation and reproducibility.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">· First batch quality is accidental (co-incidental),<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">· Second batch quality is regular (accidental),<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">· Third batch quality is validation(conformation).<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">In 2 batch we cannot assure the reproducibility of data,4 batches can be taken but the time and cost are involved.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>49. Explain about revalidation criteria of AHU system?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">AHU system shall be revalidated periodically as mentioned in the regulatory standards. AHU<br />shall be revalidated in following cases also.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in 0in 0in 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">· When basic design of AHU is changed,<br />· When clean room volume is changed,<br />· When new equipment is installed<br />· When a construction is carried out, that calls for reconstruction of AHU system.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>50. What needs to be checked during AHU validation?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">During AHU validation, following tests shall be carried out<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in 0in 0in 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">· Filter efficiency test,<br />· Air velocity & number of air changes,<br />· Air flow pattern (visualization)<br />· Differential pressure, temperature and RH<br />· Static condition area qualification<br />· Dynamic condition qualification<br />· Non-viable count<br />· Microbial monitoring<br />· Area recovery and power failure study.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>51. Position of oblong tablets to be placed in hardness tester to determine the hardness?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Lengthwise / widthwise?<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Position of oblong tablets should be length wise because the probability of breakage is more in this position.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>52. Explain in detail about qualification of pharmaceutical water system?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Qualification of pharmaceutical water system involves three phases<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">· Phase -1<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">· Phase -2<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">· Phase -3<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"> Phase -1<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">A test period of 2-4 weeks should be spent for monitoring the system intensively. During this period the system should operate continuously without failure or performance deviation. Water cannot be used for pharmaceutical manufacturing in this phase. The following should be included in testing approach.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">· Under take chemical & microbiological testing in accordance with a defined plan.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">· Sample incoming feed water daily to verify its quality.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">· Sample each step of purification process daily.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">· Sample each point of use daily.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">· Develop appropriate operating ranges.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">· Demonstrate production and delivery of product water of required quantity and quality.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">· Use and refine the SOP’s for operation, maintenance, sanitization and trouble shooting.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">· Verify provisional alert and action levels.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">· Develop and refine test failure procedure.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Phase -2<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">A further test period of 2-4 weeks. Sampling scheme will be same as Phase – 1.Water can be used for manufacturing process in this phase.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Approach should also<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in 0in 0in 0.5in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">· Demonstrate consistent operation within established ranges.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in 0in 0in 0.5in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">· Demonstrate consistent production & delivery of water of required quality and quantity.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Phase – 3<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Phase 3 runs for one year after satisfactory completion of phase-2.Water can be used for manufacturing process during this process.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Objectives & Features of Phase -3<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in 0in 0in 0.5in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">· Demonstrate extensive reliable performance.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in 0in 0in 0.5in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">· Ensure that seasonal variations are evaluated.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in 0in 0in 0.5in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">· The sample locations, sampling frequencies and test should be reduced to the normal routine pattern based on established procedures proven during Phase -1 & phase - 2.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">53. What are the recommended environmental monitoring limits for microbial<br />contamination?<o:p></o:p></span></span></b></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i><br /></i></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>54. What is the difference between calibration and Validation?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Calibration is a demonstration that, a particular Instrument or device produces results with in specified limits by comparisons with those produced by a reference or traceable standard over an appropriate range of measurements. Where as Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">In calibration performance of an instrument or device is comparing against a reference standard. But in validation such reference standard is not using. Calibration ensures that instrument or measuring devices producing accurate results. Whereas validation demonstrates that a process, equipment, method or system produces consistent results (in other words, it ensures that uniforms batches are produced).<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>55. Briefly explain about ICH climatic zones for stability testing & long term storage conditions?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in 0in 0in 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">ICH STABILITY ZONES<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in 0in 0in 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Zone Type of Climate<br />Zone I Temperate zone<br />Zone II Mediterranean/subtropical zone<br />Zone III Hot dry zone<br />Zone IVa Hot humid/tropical zone<br />Zone IVb ASEAN testing conditions hot/higher humidity<br />Long term Storage condition<br />Climatic Zone Temperature Humidity Minimum Duration<br />Zone I 21ºC ± 2ºC 45% rH ± 5% rH 12 Months<br />Zone II 25ºC ± 2ºC 60% rH ± 5% rH 12 Months<br />Zone III 30ºC ± 2ºC 35% rH ± 5% rH 12 Months<br />Zone IV 30ºC ± 2ºC 65% rH ± 5% rH 12 Months<br />Zone IVb 30ºC ± 2ºC 75% rH ± 5% rH 12 Months<br />Refrigerated 5ºC ± 3ºC No Humidity 12 Months<br />Frozen -15ºC ± 5ºC No Humidity 12 Months<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>56. What is bracketing & matrixing in stability testing?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Both Matrixing & Bracketing’s are reduced stability testing designs<br />Bracketing<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">The design of a stability schedule, such that only samples of extremes of certain design factors (ex: strength, package size) are tested at all time points as in full design. The designs assumes that the stability of any intermediate level is represented by the stability of extremes tested.<br />Matrixing<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">The design of a stability schedule, such that a selected subset of possible samples for all factor combinations is tested at a specified time point. At a subsequent time point another subset of samples for all factor combination is tested. The design assumes that the stability of each subset samples tested represents the stability of all samples at a given time point. There for a given time point other than initial & final ones not every batch on stability needs to be tested.<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>57. What are the common variables in the manufacturing of tablets?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in 0in 0in 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">· Particle size of the drug substance<br />· Bulk density of drug substance/excipients<br />· Powder load in granulator<br />· Amount & concentration of binder<br />· Mixer speed & mixing timings<br />· Granulation moisture content<br />· Milling conditions<br />· Lubricant blending times<br />· Tablet hardness<br />· Coating solution spray rate<o:p></o:p></span></span></div> <div style="background-color: white; line-height: 18.399999618530273px; margin: 0in 0in 0.0001pt; text-align: justify;"> <b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><br /></span></span></b><b><span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;"><i>58. Whether bracketing & validation concept can be applied in process validation?</i><o:p></o:p></span></span></b></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Both Matrixing & Bracketing’s can be applied in validation studies.<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Matrixing<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Different strength of same product<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Different size of same equipment<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Bracketting<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Evaluating extremes<o:p></o:p></span></span></div> <div style="background: white; line-height: 18.399999618530273px; margin: 0in; text-align: justify; text-indent: 0.5in;"> <span style="color: #333333;"><span style="font-family: Times, 'Times New Roman', serif;">Largest and smallest fill volumes<o:p></o:p></span></span></div> <div style="background: white; 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Quality Assurance : Interview Questions -Very useful for Biotech/Pharmacy Graduates/Post graduates "D7"

1. What is an SOP ? A Standard Operating Procedure (SOP) is a certain type of document that describes in a step-bystep outline form how...

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