tag:blogger.com,1999:blog-92013087880410167212024-03-14T10:26:13.467+05:30Pharma SupportSupport and value add to the pharmaceutical industry by providing continuous upgrade of knowledge and skillsPharma Supporthttp://www.blogger.com/profile/04576451206344989281noreply@blogger.comBlogger15125tag:blogger.com,1999:blog-9201308788041016721.post-15497882323388930672016-04-11T08:13:00.000+05:302016-04-11T08:16:29.771+05:30Workshop on Equipment Qualification<p class="mobile-photo"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhYDVQR1PPf8Q2ORfxav1Qn5ZWl9DgbDDRBeCr0n-dLrcUNdJ3HRTfO2nOsexkc-ykT4adFDQVeoSvpmR_2WrpBS3YiN7VC-BWopMy3IdYLB5__j8_b5ZLhurOXrTUwB0xPn3rwPXzrKaA/s1600/WP_20160406_15_29_43_Pro-789773.jpg"><img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhYDVQR1PPf8Q2ORfxav1Qn5ZWl9DgbDDRBeCr0n-dLrcUNdJ3HRTfO2nOsexkc-ykT4adFDQVeoSvpmR_2WrpBS3YiN7VC-BWopMy3IdYLB5__j8_b5ZLhurOXrTUwB0xPn3rwPXzrKaA/s320/WP_20160406_15_29_43_Pro-789773.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_6272124527355571970" /></a></p><p class="mobile-photo"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgkp2y8InZVc2l7PeojbLTd8E3ha8l8VTj6L27RPKgjmSlVzLFzfF-uibBR495DsavM5kGr3aRTvcx5EQqY8e25lo7CQWJ8rsXAGLAtWF2aEODsmSOVfoVmc_tbJ7sI04KaYceqBhG_VCg/s1600/WP_20160406_18_00_47_Pro-791055.jpg"><img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgkp2y8InZVc2l7PeojbLTd8E3ha8l8VTj6L27RPKgjmSlVzLFzfF-uibBR495DsavM5kGr3aRTvcx5EQqY8e25lo7CQWJ8rsXAGLAtWF2aEODsmSOVfoVmc_tbJ7sI04KaYceqBhG_VCg/s320/WP_20160406_18_00_47_Pro-791055.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_6272124531052547330" /></a></p><div><div style="font-family: Calibri,sans-serif; font-size: 11pt;">At Hotel Fern, Ahmedabad with participants from 3 units of Teva Pharma.<br>The concept of URS, FS, DS, DQ, FAT, SAT, IQ, OQ, PQ, PPQ, Validation, Verification, Calibration, Monitoring and Control were discussed and practised.<br>The group was extremely participative and knowledgeable and cases from their practical situation were discussed.<br><br></div></div>Pharma Supporthttp://www.blogger.com/profile/04576451206344989281noreply@blogger.com0tag:blogger.com,1999:blog-9201308788041016721.post-22055710696819176452016-02-25T21:55:00.000+05:302016-02-25T22:02:01.782+05:30CAPA at Sri Krishna Pharmaceuticals, Hyderabad <p class="mobile-photo"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgrb1ALrXOow4yirtD1rGJKbVHCz-ovlMpcjoRAp_oUasEt7dJpmrh5mp7Hz1bWH6r9epzzIATFshab7kV0_GL7z9ULq0X4wMLt4yI1vp33EMUxLiEwOW76lQ2GJ7Xc9ITJX_Kq4dASXQA/s1600/WP_20160223_13_20_16_Pro-721783.jpg"><img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgrb1ALrXOow4yirtD1rGJKbVHCz-ovlMpcjoRAp_oUasEt7dJpmrh5mp7Hz1bWH6r9epzzIATFshab7kV0_GL7z9ULq0X4wMLt4yI1vp33EMUxLiEwOW76lQ2GJ7Xc9ITJX_Kq4dASXQA/s320/WP_20160223_13_20_16_Pro-721783.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_6255267345909931378" /></a></p><p class="mobile-photo"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjZN75e4CQsgTp_zO451fsEtc5NjzJKsZSM6fu0lswViUpeREak8_sIXr0NJwP6AAC44uavg7QVgDs1aqn8bF457bqzPxHNiYPUVLKYtfUtphIZw7CIuPuLaP3XnziUUZb7kA400PNCxw0/s1600/WP_20160223_13_20_33_Pro-723561.jpg"><img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjZN75e4CQsgTp_zO451fsEtc5NjzJKsZSM6fu0lswViUpeREak8_sIXr0NJwP6AAC44uavg7QVgDs1aqn8bF457bqzPxHNiYPUVLKYtfUtphIZw7CIuPuLaP3XnziUUZb7kA400PNCxw0/s320/WP_20160223_13_20_33_Pro-723561.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_6255267350046081586" /></a></p><p class="mobile-photo"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgk91UIm8Sr6_kcnlER-oVFyPGCuxu7sCCXfALuASGdWXiydKch8OoYeMUqEhs2UChyKSeiSAx0pKXF1A11haWOxqH7nSdNlftsT7Ped2R67d8Ua0qsXM_uWtdNdAX8fEgCweQuWaJwyk8/s1600/WP_20160223_17_44_49_Pro-725679.jpg"><img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgk91UIm8Sr6_kcnlER-oVFyPGCuxu7sCCXfALuASGdWXiydKch8OoYeMUqEhs2UChyKSeiSAx0pKXF1A11haWOxqH7nSdNlftsT7Ped2R67d8Ua0qsXM_uWtdNdAX8fEgCweQuWaJwyk8/s320/WP_20160223_17_44_49_Pro-725679.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_6255267357452494594" /></a></p><div><div style="font-family: Calibri,sans-serif; font-size: 11pt;">February 23rd and 24th 2016saw senior managers of Sri Krishna Pharmaceuticals spend time with Pravin Manker who facilitated a workshop on CAPA with live case studies from their 4 manufacturing units.<br><br>50 participants spent their time and energy vigorously discussing steps in CAPA starting with defining the deviation statement, failure investigation and root cause analysis.<br><br>Tools such as 5 why analysis, brainstorming, fishbone diagram, FMEA were put to practical use with robust debating among 4 groups formed with cross-unit and cross-functional team formation.<br><br>Overall the program was well received with many participants pledging to put the techniques learnt to practical use. <br><br>The highlight of the program was the presence of the Managing Director for a large part of the program showing the importance the company gives to training.</div></div>Pharma Supporthttp://www.blogger.com/profile/04576451206344989281noreply@blogger.com0tag:blogger.com,1999:blog-9201308788041016721.post-19986400056225631882016-02-20T01:50:00.000+05:302016-02-20T01:51:00.104+05:30Fwd: Hetero Vizag CAPA<p class="mobile-photo"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjkCPGZKGipHbC4Vk_FrYQUkYBXvD86IMHI9EdxhKAX7pYNicAglc1D5BBWqFSmKoqzhdy209YfNinjnrx1COYL906AQUDZBXAPUDRHUu6MNd0UDjjNtspXbTadTotSs6SC4gIogDB1V7k/s1600/WP_20160217_12_19_44_Pro-760105.jpg"><img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjkCPGZKGipHbC4Vk_FrYQUkYBXvD86IMHI9EdxhKAX7pYNicAglc1D5BBWqFSmKoqzhdy209YfNinjnrx1COYL906AQUDZBXAPUDRHUu6MNd0UDjjNtspXbTadTotSs6SC4gIogDB1V7k/s320/WP_20160217_12_19_44_Pro-760105.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_6253099840777452626" /></a></p><p class="mobile-photo"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj84BNYzs8bwskjF2TEICKrVMyc4exjjdr1XyL97mSDYWGY0NtVa5OyYiyAnJzfvLztlfHr9Hzny9IqUGVvqMEKUYi3l9GTbwRUn0bJe5GOQW6bjSqzv2avxkU1a7aHIHp11cdpyBEvI9I/s1600/WP_20160217_12_20_52_Pro-763028.jpg"><img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj84BNYzs8bwskjF2TEICKrVMyc4exjjdr1XyL97mSDYWGY0NtVa5OyYiyAnJzfvLztlfHr9Hzny9IqUGVvqMEKUYi3l9GTbwRUn0bJe5GOQW6bjSqzv2avxkU1a7aHIHp11cdpyBEvI9I/s320/WP_20160217_12_20_52_Pro-763028.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_6253099851234190930" /></a></p><p class="mobile-photo"><a 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src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhRIawrpFrS9d3znyv7H05X9WOeNlrpjQ80LIOPHXIjAiZT73RUp9_o0MQhvuGJcgGbr6utxhebBtFjQJ3KDhESyj5tOLBRm0q6DiYH_ZcS3y_9T6hCiuQ96K9uA956t8IrdwFo4RK2KNc/s320/WP_20160217_12_21_35_Pro-770073.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_6253099880699306210" /></a></p><p class="mobile-photo"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgbDdJWSrgWByMn_Oiv-BmNcazZMLEQUtQzNv5RAuC5rCCpM4FGkrm0BHWV0JfiTV262XnkIOj8nlUCM82fL0E2unYhOPP6sq3DYUmbr3zdAFc5UVMqzpqoAhUT5pjEWxu6FBYnfu4HjcA/s1600/WP_20160217_12_21_41_Pro-772803.jpg"><img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgbDdJWSrgWByMn_Oiv-BmNcazZMLEQUtQzNv5RAuC5rCCpM4FGkrm0BHWV0JfiTV262XnkIOj8nlUCM82fL0E2unYhOPP6sq3DYUmbr3zdAFc5UVMqzpqoAhUT5pjEWxu6FBYnfu4HjcA/s320/WP_20160217_12_21_41_Pro-772803.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_6253099895750316770" /></a></p><p class="mobile-photo"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi_Hdq9NUdPFN-dSfGvaccot-4Dctj_rfTUhW9M51QNTTZeBY2SvkkKU8lGSDrDG6zK87cLrZ9KQpOQX2Lu1XEibDQghOegPDze4ekFeO_vBnpwkXbWQW8v4ejn98X6KQuWGn_cbjrB1Dw/s1600/WP_20160217_13_18_43_Pro-775944.jpg"><img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi_Hdq9NUdPFN-dSfGvaccot-4Dctj_rfTUhW9M51QNTTZeBY2SvkkKU8lGSDrDG6zK87cLrZ9KQpOQX2Lu1XEibDQghOegPDze4ekFeO_vBnpwkXbWQW8v4ejn98X6KQuWGn_cbjrB1Dw/s320/WP_20160217_13_18_43_Pro-775944.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_6253099907738419314" /></a></p><p class="mobile-photo"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhh5lZN8w3pedpWYIyk7bWY2LEB_e0GFcrzPKmk94dp02I3bfrFM15050V06MFLvyQ7E1Bp3NPgKucpUsCr-Ij-jtaEza3XEfHHUzPQA_8OZ3386Inz69tkkRd5920Lhk35CwhkhQQLXZQ/s1600/WP_20160218_15_05_10_Pro-778135.jpg"><img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhh5lZN8w3pedpWYIyk7bWY2LEB_e0GFcrzPKmk94dp02I3bfrFM15050V06MFLvyQ7E1Bp3NPgKucpUsCr-Ij-jtaEza3XEfHHUzPQA_8OZ3386Inz69tkkRd5920Lhk35CwhkhQQLXZQ/s320/WP_20160218_15_05_10_Pro-778135.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_6253099918842484850" /></a></p><div dir="ltr"><div class="gmail_quote"><div><div><div style="font-family:Calibri,sans-serif;font-size:11pt">Two days workshop on CAPA for Assistant Managers and above on 17th and 18th February 2016 at Hetero Nakkapalli plant.<br><br>60 participants worked on in house case studies and applied their minds in 7 groups.<br>Identification (Problem Definition)<br>Evaluation<br>Deviation Investigation<br>Analysis (RCA)<br>Corrective Action<br>Preventive Action<br>Follow-up<br>were discussed in a lively, robust yet friendly manner. <br><br>The workshop was conducted by Prescription Pharma Support, a Mumbai based service provider to the Pharmaceutical industry worldwide.<br><br>The workshop leader was Pravin Manker</div></div></div></div><div><br></div><div class="gmail_signature"><div dir="ltr"><div><a href="mailto:pmanker2005@yahoo.com" target="_blank"></a></div></div></div> </div> Pharma Supporthttp://www.blogger.com/profile/04576451206344989281noreply@blogger.com0tag:blogger.com,1999:blog-9201308788041016721.post-34893628827960961192016-01-29T09:06:00.000+05:302016-01-29T09:12:16.207+05:30Team Building and Effectiveness<p class="mobile-photo"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEij02c_-a3adOA1t56xxHIMgQ6mhAUy7rM2FjEhSumpeGqKxDQYbDOtuYmbEX3NRtGNgtEJr9DaYnz4avGosAfEmLxynmDt5R77UKa7ZP5FcHbJOpN3y3HmVNXFK5mVxWXIsRUBjxKw72o/s1600/WP_20160127_17_30_18_Pro-736208.jpg"><img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEij02c_-a3adOA1t56xxHIMgQ6mhAUy7rM2FjEhSumpeGqKxDQYbDOtuYmbEX3NRtGNgtEJr9DaYnz4avGosAfEmLxynmDt5R77UKa7ZP5FcHbJOpN3y3HmVNXFK5mVxWXIsRUBjxKw72o/s320/WP_20160127_17_30_18_Pro-736208.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_6245049680044895074" /></a></p><p class="mobile-photo"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgQ2PMb1jjfpFn7ZxIBeRaSDkn7dr_GwHtH6vc2h-VHU9EjBBUhBqma7-SDW9kv1PErLD4GXgHnsG9CxWlkwZIC2FVcEh_s-c7biqXm4_o08nAQMRa6Ezv_Ryn8sPeOTPvNAZGQ1xjDM6I/s1600/WP_20160127_17_31_00_Pro-739015.jpg"><img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgQ2PMb1jjfpFn7ZxIBeRaSDkn7dr_GwHtH6vc2h-VHU9EjBBUhBqma7-SDW9kv1PErLD4GXgHnsG9CxWlkwZIC2FVcEh_s-c7biqXm4_o08nAQMRa6Ezv_Ryn8sPeOTPvNAZGQ1xjDM6I/s320/WP_20160127_17_31_00_Pro-739015.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_6245049692477393570" /></a></p><p class="mobile-photo"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhbMhlQrSiUJoqutTQu74HztJbnRBjHalon7Rsw-_ZhbJPdJjfj6d4A9-EqMsUWmRPMU_CEA7Fz1kg8WORJpxVSGWmcAmpV5A7WuQmb-vdXONGgS8j5A7qbhpIVUqS6c8sCaEGJ_jhc6eE/s1600/WP_20160127_17_38_06_Pro-740883.jpg"><img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhbMhlQrSiUJoqutTQu74HztJbnRBjHalon7Rsw-_ZhbJPdJjfj6d4A9-EqMsUWmRPMU_CEA7Fz1kg8WORJpxVSGWmcAmpV5A7WuQmb-vdXONGgS8j5A7qbhpIVUqS6c8sCaEGJ_jhc6eE/s320/WP_20160127_17_38_06_Pro-740883.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_6245049701303385522" /></a></p><p class="mobile-photo"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg8bydOSqEBENWu5OcJUc6oNVeVKBam9HlNT5lT01pvazCZgrpTMDR6ccioMiq5R78aAghu59ddGldH57m91sKm9-v26YnPKCrPy-WaAGyNN8fG8uOiZFH4bBAdYX-vfQfpNnu7IaqWByQ/s1600/WP_20160127_001-743656.jpg"><img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg8bydOSqEBENWu5OcJUc6oNVeVKBam9HlNT5lT01pvazCZgrpTMDR6ccioMiq5R78aAghu59ddGldH57m91sKm9-v26YnPKCrPy-WaAGyNN8fG8uOiZFH4bBAdYX-vfQfpNnu7IaqWByQ/s320/WP_20160127_001-743656.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_6245049707388883314" /></a></p><div><div style="font-family: Calibri,sans-serif; font-size: 11pt;">A workshop and training program held in Hyderabad for S. K. Pharmaceuticals on 27/1 and 28/1/16 for cross-functional Senior Managers and HODs.<br><br>36 members participated and were put through the theory and practical case studies on forming, storming, morning and performing, Do's and Don'ts, Team Building, Communication skills, Leadership skills and Good Habits to Develop.<br><br>The two days were intense, interactive and enjoyable with multiple takeaways for participants.</div></div>Pharma Supporthttp://www.blogger.com/profile/04576451206344989281noreply@blogger.com0tag:blogger.com,1999:blog-9201308788041016721.post-87838983849841227602016-01-14T13:08:00.001+05:302016-01-14T13:08:48.431+05:30Fwd: Attitude towards GMP<p class="mobile-photo"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhE5BCdh5bjkGZ5c6_FXzZR0KsEPp7Q0fgCZwYrMxcpA_CuqiKqLdLIzJkJOkmMWYLHTjinr-R9uRv11RdCxcfeHIh5IwZ5Wf_ROwYElH7Vl3L4NRfar6eBcpxUA-_VQN01VkoeQf8oJpE/s1600/WP_20151230_15_47_51_Pro-728432.jpg"><img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhE5BCdh5bjkGZ5c6_FXzZR0KsEPp7Q0fgCZwYrMxcpA_CuqiKqLdLIzJkJOkmMWYLHTjinr-R9uRv11RdCxcfeHIh5IwZ5Wf_ROwYElH7Vl3L4NRfar6eBcpxUA-_VQN01VkoeQf8oJpE/s320/WP_20151230_15_47_51_Pro-728432.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_6239544360124113282" /></a></p><p class="mobile-photo"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjxOp3HJutzUCwFZgIHZr8Dx1WwYBWF0U4QMB2rqqVr94SP0ZVIMuRoDqT7thgk58spA8DMYECE-Dj21rLIH_DHsO_w4m3X73y8fwvq11WFlbL_bbtvQq9bOyRB0vgdDdKfYN0ZupI_8gI/s1600/WP_20151230_15_48_45_Pro-731276.jpg"><img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjxOp3HJutzUCwFZgIHZr8Dx1WwYBWF0U4QMB2rqqVr94SP0ZVIMuRoDqT7thgk58spA8DMYECE-Dj21rLIH_DHsO_w4m3X73y8fwvq11WFlbL_bbtvQq9bOyRB0vgdDdKfYN0ZupI_8gI/s320/WP_20151230_15_48_45_Pro-731276.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_6239544375212906738" /></a></p><p class="mobile-photo"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhV3d1PFm9ovIEp4MOg0H5l84TwgIs1xItxn0RlFzsbOYbSfnF9Kj59MdeoQaoC81w8ZNSpv1YbnAyXjqZkPoHxLp8sL4A_eVJtEpJ28me_3NRV4XmU3K5HQJDQdsCqNKNjIYgMSY0K9QU/s1600/WP_20151230_15_50_41_Pro-734488.jpg"><img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhV3d1PFm9ovIEp4MOg0H5l84TwgIs1xItxn0RlFzsbOYbSfnF9Kj59MdeoQaoC81w8ZNSpv1YbnAyXjqZkPoHxLp8sL4A_eVJtEpJ28me_3NRV4XmU3K5HQJDQdsCqNKNjIYgMSY0K9QU/s320/WP_20151230_15_50_41_Pro-734488.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_6239544385751620770" /></a></p><p class="mobile-photo"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEilzp0-wGX9UUID-_pIIFaLJkyI6KxL1wQANOtL3nqO_E_hvfDTM8UFsbp0ugslmHyH8IlW90kQ3criNk0s3a0R6PlXa_QK7TAZAWYdGfyyDEe-uZ6mGEafBEQ_C4t_O5t9l3M_80P_TAo/s1600/WP_20151231_12_50_21_Pro-737234.jpg"><img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEilzp0-wGX9UUID-_pIIFaLJkyI6KxL1wQANOtL3nqO_E_hvfDTM8UFsbp0ugslmHyH8IlW90kQ3criNk0s3a0R6PlXa_QK7TAZAWYdGfyyDEe-uZ6mGEafBEQ_C4t_O5t9l3M_80P_TAo/s320/WP_20151231_12_50_21_Pro-737234.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_6239544395060139810" /></a></p><p class="mobile-photo"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj-V5bWL_a2ycMt7olvFfOCwXAai4rANR475Tu5fuKp3a8iz5nI-XKMGznRIWO2LCidTh9bDQXkuXftxubPvGYgzXD300M0qLVNiOiSnPRBIaxdkQIsMVWlgT5RoyNspzW7QoESYo7J44U/s1600/WP_20151231_14_21_54_Pro-739508.jpg"><img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj-V5bWL_a2ycMt7olvFfOCwXAai4rANR475Tu5fuKp3a8iz5nI-XKMGznRIWO2LCidTh9bDQXkuXftxubPvGYgzXD300M0qLVNiOiSnPRBIaxdkQIsMVWlgT5RoyNspzW7QoESYo7J44U/s320/WP_20151231_14_21_54_Pro-739508.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_6239544408504211570" /></a></p><div dir="ltr"><br><div class="gmail_quote"><br>Subject: Attitude towards GMP</div><div class="gmail_quote"><br><font face="Calibri, sans-serif"><span style="font-size:14.6667px">cGMP training programs are usually boring and technical because most people think they know all about GMP. It is not the content of GMP that is critical but the attitude of people who are expected to adopt GMP. Many GMP failures have occurred not because people were ignorant but because people did not have the right attitude. Ironically, the attitude cuts across the vertical hierarchical structure of an organization. </span></font></div><div class="gmail_quote"><font face="Calibri, sans-serif"><span style="font-size:14.6667px"><br></span></font></div><div class="gmail_quote"><font face="Calibri, sans-serif"><span style="font-size:14.6667px">Also, a level of complacency develops when an organization has gone through a few successful FDA and MHRA GMP audits. This complacency percolates down the line because a cross-section of employees, who know the flaws in their organizations, start believing that we can 'fool' all the auditors all the time.</span></font><br><br><div><div><div style="font-family:Calibri,sans-serif;font-size:11pt">A unique two-days workshop blending principles governing life and GMP was initiated on 30th December 2015 by Prescription Pharma Support, Mumbai and Sri Krishna Pharmaceuticals, Hyderabad.<br><br>Top officials from 4 manufacturing units, about 40 in number, participated. The departments represented were Manufacturing, Technical ServicesQC, QA, IT, HR, R&D, Warehouse, Engineering and Corporate Managers participated.<br><br>Laws of living and their relevance in professional life was the highlight of day 1. The backdrop was Lord Buddha's noble 8-fold path. This was organized in a meeting setup.<br><br>The second day was rearranged as clusters with teams formed from the members of the 4 units applying cross-functional and cross-locational mix. <br><br>Live case studies were discussed relating the noble 8-fold path to understanding deviations, investigations, root cause analysis, writing SOPs and communication skills.<br><br>The unique experiment was well received and the participants and corporate managers expressed delight at the outcome of two fruitful days.</div></div></div></div><br><br clear="all"><div><br></div><div class="gmail_signature"><div dir="ltr"><div><br><a href="mailto:pmanker2005@yahoo.com" target="_blank"></a></div></div></div> </div> Pharma Supporthttp://www.blogger.com/profile/04576451206344989281noreply@blogger.com0tag:blogger.com,1999:blog-9201308788041016721.post-32971988392027539622015-05-16T01:45:00.001+05:302015-05-16T01:45:46.346+05:30A novice through the maze of Data Integrity!<div dir="ltr">Let's begin with <i><u>what is data</u></i>?<br><div><div dir="ltr"> <div><br><a href="mailto:pmanker2005@yahoo.com" target="_blank"></a></div><div>Facts of statistics, known or assumed, collected together manually or automatically, for reference or analysis. Since data is collected, measured, reported and analysed it transforms from raw unorganized bits of values or statements to patterns or images or graphs that reveal some information.</div><div><br></div><div>Thus data, for example, could be a set of values revealing the temperature of a room over different hours of the day over a number of days. It could also be a compilation of "go/no go" report such as "pass" or "fail" statement for the number of batches produced over a specified period of time.</div><div><br></div><div><i><u>What is integrity</u></i>?</div><div><br></div><div>In a person it is the quality of being honest and having strong moral principles. In data it is a state of being whole (undivided) and incorruptible over a specified period of validity. If we apply the yardstick of honesty to data, it would translate into truthfulness and reliability.</div><div><br></div><div>Thus data integrity could be defined as a truthful and reliable set of values, images, reports or graphs collected over a specified time period generated through the operation of a process.</div><div><br></div><div>In the computer world, data is facts and figures stored in and processed by a an electronic device. In the world of statistics, data is facts and figures from which conclusions can be drawn. D<span style="color:rgb(0,0,0);font-size:12.8000001907349px"><font face="arial, helvetica, sans-serif">ata that have been recorded, classified, organized, related, or interpreted within a framework so that a meaning emerges, is known as <i><u>information</u></i>. A</font></span><span style="color:rgb(0,0,0);font-size:12.8000001907349px"><font face="arial, helvetica, sans-serif"> type of information obtained through mathematical operations on numerical data is <i><u>statistics</u></i>.</font></span></div><div><span style="color:rgb(0,0,0);font-size:12.8000001907349px"><font face="arial, helvetica, sans-serif"><br></font></span></div><div><span style="color:rgb(0,0,0);font-size:12.8000001907349px"><font face="arial, helvetica, sans-serif">Basically, it emerges that data is essentially a collection of facts and figures for onward processing through sifting, organizing, analyzing and concluding to give desired information for decision making. The decision made can be as right as the data collected and maintained. Herein lies the crux of data integrity.</font></span></div><div><span style="color:rgb(0,0,0);font-size:12.8000001907349px"><font face="arial, helvetica, sans-serif"><br></font></span></div><div><span style="color:rgb(0,0,0);font-size:12.8000001907349px"><font face="arial, helvetica, sans-serif">Danger to data integrity is data corruption or data loss. Data corruption are errors that occur during collection, storage, transmission and processing of data. It is significant to note that interpretation of data is not included in the above. Interpretation is subjective and the same data can be interpreted differently by different individuals to meet different goals. Errors can occur through hardware or software malfunction. Here is a snapshot of data corruption obtained from wikipedia</font></span></div><div><span style="color:rgb(0,0,0);font-size:12.8000001907349px"><font face="arial, helvetica, sans-serif"><br></font></span></div><div><img src="http://upload.wikimedia.org/wikipedia/commons/thumb/6/63/Data_loss_of_image_file.JPG/220px-Data_loss_of_image_file.JPG"> Production of unaccepted results is data corruption. The unaccepted result could be a minor loss of data or a total system failure.<span style="color:rgb(0,0,0);font-size:12.8000001907349px"><font face="arial, helvetica, sans-serif"><br></font></span></div><div><br></div><div>Corruption of data comes in two shades, the undetected and the detected. The undetected is also referred to as silent data corruption as there is no indication that the data is incorrect and this is the most dangerous type of corruption. Detected corruption may lead to permanent loss of data or a temporary malfunction which is auto-corrected through in-built mechanisms (software) and does not result in data loss. For example the auto save function which prevents data loss in case of battery drain while using a laptop.</div><div><br></div><div>Data corruption can occur at any stage from data acquisition, transmission, storage, processing and retrieval. The causes of data loss are hardware oriented or software related. Interruption during data transmission can also cause data loss. Cosmic rays from increased solar activity, cloud cover, microwaves, electrical fluctuations, loose connections, background radiation, external disturbances like loud sound, aging, viruses and human error can lead to data loss or corruption.</div><div><br></div><div>Data can be secured in a number of ways. Multiple layers of defense mechanisms can protect data should there be a deliberate or incidental breach either internally or through the net. Introducing programmable logic controls like levels of authority, passwords, authentication like biometrics, firewalls, anti-virus, anti spyware, anti-malaware and encryption are some methods that may be employed. Physically, restrict access through locks on servers and storage cabinets.</div><div><br></div><div>Access control and access records are other methods to discourage espionage, hacking and pilfering of data. In which case access control should be made robust through key-code changes and combination lock changes pretty regularly. Changing passwords and restricting access are obvious choices but it is in obvious areas that carelessness creeps in.</div><div><br></div><div>Data transfer should be done over safe networks and very discreetly. This translates into keeping a low profile on data handling and storage. Maintain a data log of who accessed the data, where and when and keep the control by periodic questioning of the purpose behind the access.</div><div><br></div><div>Keep the security system transparent so that it becomes an effective auto-check mechanism. Don't let obsessive security affect productivity. Ensure online and offline back-ups and make sure that the back-ups are not corrupted or inaccessible by periodic and controlled access, duly recorded. Validate data recovery processes.</div><div><br></div><div>Who can help manage data integrity? The obvious choice would be vendors of storage hardware, Exchange notes with software vendors how they maintain their data and secure their operations.</div><div><br></div><div>Data management also includes data redundancy and elimination much like archiving old documents. Scan disk and similar programmes keep the system robust and improve detectability of impending malfunction so that appropriate steps may be taken before damage occurs. This is also preventive and predictive maintenance.</div><div><br></div><div>Why do we need data management and data integrity? Primarily because it is a legal requirement to have accurate history with a proven audit trail. Secondly because organizational culture can be evaluated on the basis of data integrity.</div><div><br></div><div>India as a nation has suffered at the hands of handful of companies that could not and did not secure their data. That the world took pot shots at integrity was a heavy price a nation paid and is still paying!</div><div><br></div><div><br></div><div><br></div><div><br></div><div><br></div><div><br></div><div><span style="color:rgb(0,0,0);font-size:12.8000001907349px"><font face="arial, helvetica, sans-serif"><br></font></span></div><div><span style="color:rgb(0,0,0);font-size:12.8000001907349px"><font face="arial, helvetica, sans-serif"><br></font></span></div></div></div> </div> Pharma Supporthttp://www.blogger.com/profile/04576451206344989281noreply@blogger.com0tag:blogger.com,1999:blog-9201308788041016721.post-65491951464402596312015-05-12T10:23:00.001+05:302015-05-12T10:23:01.457+05:30Quality Risk Management (QRM) in Pharmaceutical Manufacturing<div dir="ltr">Two major elements in Quality Risk Management (QRM) areas follows:<br clear="all"><div><br></div><span style="color:black;font-family:Arial">The evaluation of the risk to quality should be based on <u><b>scientific knowledge</b></u> and ultimately link to the protection of the patient </span><div><span style="color:black;font-family:Arial"><br></span></div><div><span style="color:black;font-family:Arial">The <b><u>level of effort</u></b>, formality and <u><b>documentation</b></u> of the quality risk management process should be commensurate with the level of risk</span></div><div> <br><div><div dir="ltr"><div>It appears from both the points above that ALL RISK is therefore, associated with PEOPLE. working in a Pharmaceutical manufacturing and testing environment. Scientific knowledge, level of effort and documentation are all person-related activities.</div><div><br></div><div><i><b>Risk is defined as </b></i><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px"><i><b>a situation involving exposure to danger.</b></i> </span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px"><br></span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px">What danger are we referring to? Danger to the quality of the product which translates as danger to the patient consuming the product. Before we look a the danger to the quality, let us consider danger to the patient.</span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px"><br></span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px">A poor quality product may not produce the desired result, which means it is not efficacious. It may be unsafe, harmful. The harm can be as severe as death. </span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px"><br></span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px">Efficacy and safety of the product can be affected by several factors and all these factors are contributed by the action or inaction of people involved from Product Development to product sale, distribution, diagnosis and administration.</span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px"><br></span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px">Some of those factors are:</span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px"><br></span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px">1. <i><b>Material</b></i>: Right from selection of material at Product Development stage, risk has been activated. Scientific knowledge is the limitation of the scientist involved in research and formulation development. Material selection begins with material specification and vendor finalization. While specifying parameters and acceptance criteria, it is possible to miss out on tests that should have been in place. Sometimes lack of analytical ability can lead to absence of a test from an official protocol. Then there is the mundane activity of material storage and handling which being mundane, increases the risk. We can trail the material and find several risk points along the way and all will be associated with people and their action or inaction. </span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px"><br></span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px">2.<i style="font-weight:bold"> Machine</i><b><i>s</i></b>: Again, machines are selected, installed, operated and maintained by people and it is their level of knowledge and skill in doing each of the above, that determines the risk to the quality of the product.</span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px"><br></span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px">3. <b style="font-style:italic">Method</b>: All methods, from development, execution and documentation are the handiwork of people and if tried and tested methods are not followed due to lack of understanding, training, skill, discipline and supervision, the risk will increase.</span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px"> </span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px">4. <b><i>Metres</i></b> (manufacturing and testing environment) Spaces are conceived, designed, used and maintained by people. The concept and design is done by a different set of people and the user of space is a different individual and many a times there is a mismatch in what was conceived and what was adopted in operations. We therefore have situations like "as designed" and "as built".</span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px"><br></span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px">5. <b><i>Minutes</i></b>: Time of manufacturing is crucial. Factories operate in shifts and human efficiency is questionable at different times of the day. Afternoons and nights are not the most conducive times for human alertness. </span><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px">Moreover, all people involved with activities are driven by the commercial aspect of the enterprise. And time is money! So there is always a pressure on operating staff to deliver results within the specified time. Haste makes waste and performing under time crunch situations multiplies the risk.</span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px"><br></span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px">6.<b><i> Maintenance</i></b>: is a culture. Maintaining premises and equipment is commonly understood. Maintaining documents is also considered normal. The difficult thing to maintain is discipline and here again we are talking of people. It i lack of discipline that allows infrastructure and equipment to malfunction and degenerate.</span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px"><br></span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px">7. <b><i>Monitoring</i></b>: Though advancement in technology has given us gadgets like camera and recording devices, it still takes people to monitor the data collected to derive meaningful information from the same. Monitoring means observing and reporting and here again the reliance is on people. No wonder we have failures despite the best of installations of hardware and software.</span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px"><br></span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px">8. <b><i>Measurement</i></b>: The route to accuracy is measurement because it is objective. Accuracy depends on the availability of measuring devices and the ability to use those devices. But importantly, people have to "look at" measurements. We see instances of measurements being recorded (quite a few by automatic devices), but nobody sees those measurements or tracks the trends or derives any information out of those measurements. The measurements are piled up as raw data without any practical application. Another "people" issue!</span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px"><b><i><br></i></b></span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px">9.<b style="font-style:italic"> Modification</b>: The urge to modify is inherent in humans. If it is a controlled modification then we are within the ambit of change control but when it comes to an impulsive modification then we enter the realm of deviation. We are witnessing the amount of strictures regulators apply when it addresses deviations.</span></div><div><span style="font-family:arial,sans-serif-light,sans-serif;line-height:15.6000003814697px"><br></span></div><div>10.<b><i> Manipulation</i></b>: One thing leads to another and in the mode of defense, to hide the origin "sin" people resort to manipulating. Doctoring of documents has been a malaise that the regulators are coming down heavily upon and is reflected in their strict stance against some companies. While we are using diplomatic language, the simple word in English for manipulation is "cheating".</div><div><br></div><div>11. <b><i>Mistakes</i></b>: Being what human beings are, it is in natural progression that mistakes are bound to happen. It is "how" those mistakes are dealt with that reduces or enhances the risk to quality. When mistakes happen the immediate human response is denial. Usually it is out of fear of consequences. The play of people is quite 'unmistakable'. </div><div><br></div><div>12. <b><i>Management</i></b>: It is the top management that sets the tone. If the top is commercially oriented, almost every time there is a conflict between quality and commerce (and this conflict exits on nd off), invariably the commerce wins.</div><div><br></div><div>13. <b><i>Motivation</i></b>: Strictly a people's subject, it is a double-edged sword. If people are not self-motivated by the fact that their work causes healing in the world, and if they have to depend on external motivating factors such as incentives, then it is a given that in the absence of those factors, the people will not be motivated enough to give of their best. </div><div><br></div><div>14. <b><i>Market</i></b>: If my product quality is based on the market to which I am catering, I am acknowledging that I have multiple standards of quality. This is again a matter of attitude and organizational culture which in turn is a "people" subject.</div><div><br></div><div>15. <b><i>Money</i></b>: has always fascinated people and it is the singular most powerful driving force visible in humanity. Why are more and more companies gearing up to raise their quality standards? Simple! The markets that demand the higher levels of quality standards pay premium prices for drug products. So if money is a motivator, then while actually improving quality and thereby reducing risks, people are also running the risk of "showing" that their quality is improved. That is riskier!</div><div><br></div><div>16.<b><i> Mapping</i></b>: This is generally about audit trail. If you can map the route through which a product has traveled from its development stage till its final consumption in the market or its expiry, then you have charted a good map. A map can be used for gap analysis and enhancing reliability by bridging the gaps. This is where flow-charting becomes an important Process Control tool. When a Process is brought under stricter control the risk is minimized. Good mapping is also dependent on the knowledge, skills, diligence and perseverance of people.</div><div><br></div><div>17. <b><i>Mastery</i></b>: QRM tools are available to all. But tools require skills to be used. A screw driver is a tool, which in the hands of a skillful carpenter can fix a piece of furniture. The same screw driver in the hands of a skillful electrician can illumine a room. If the respective departments in an organization can use the tools offered under QRM effectively, then there will be a meaningful reduction in risks. Knowledge of the tool and the skill to use it is entirely up to the people. This is the realm of personnel selection, education and training. Unfortunately training is being treated as a regulatory obligation to be fulfilled and not as an essential aspect of risk-free manufacturing and testing.</div><div><br></div><div>18. <b><i>Mission</i></b>: Most organizations have mission statements. Only few take the effort to have the mission percolate down to all levels of people in the organization. A very tiny percentage ensures that the Mission is revisited, revised and kept alive in all strata of the organization.</div><div><br></div><div>If one has to go into details of each factor, it becomes a big exercise in HR management. But if one does invest in such an activity, the QRM becomes child's play. Risk Management exists because risks exist. Risks exist because of people's inadequacies. Inadequacies in knowledge, skills, management, monitoring and control exist in the best of organizations. Risk identification, risk analysis and risk mitigation becomes easier with enhanced knowledge and improved skill sets. Investing in educating and training people is as vital as investing in infrastructure and equipment.</div><div><br></div><div>Hopefully the industry will see the savings (money again) in this investment and take concrete steps in this direction.</div><div><br></div><div><br></div><div><br></div><div>18. </div><div><br></div><div><br></div><div><br></div><div><a href="mailto:pmanker2005@yahoo.com" target="_blank"></a></div></div></div> </div></div> Pharma Supporthttp://www.blogger.com/profile/04576451206344989281noreply@blogger.com0tag:blogger.com,1999:blog-9201308788041016721.post-8645896829639361152015-05-01T13:16:00.001+05:302015-05-01T13:16:24.673+05:30Correction: Personnel Hygiene<div dir="ltr">"Personal is inwards" instead or "Personnel is inwards"<br><div class="gmail_signature"><div dir="ltr"> <div><br><a href="mailto:pmanker2005@yahoo.com" target="_blank"></a></div></div></div> </div> Pharma Supporthttp://www.blogger.com/profile/04576451206344989281noreply@blogger.com0tag:blogger.com,1999:blog-9201308788041016721.post-86410851134493877422015-05-01T13:12:00.001+05:302015-05-01T13:12:47.460+05:30EU GMP - Personnel Hygiene or Personal Hygiene?<div dir="ltr">It is a matter of perspective!<div><br></div><div>Personnel is is inwards; about the self! Personnel is outward; about someone else.</div><div><br></div><div>When you point a finger outward, just turn the wrist 180 degrees and you will see three fingers pointing back at you. So all those who are in managerial positions and who conduct training programs need to look inward about their personal hygiene before they teach personnel hygiene.</div><div><br></div><div>We conceive and deliver what and who we are. A human delivers a human being just as any other species delivers its own kind. By the same law, a clean person will deliver a clean system and a clean environment for the manufacture of a clean drug product.</div><div><br></div><div>Again, a human being is not a machine to be switched on or off. An unclean person at home cannot be switched on to be clean at his place of work. Clean habits begin at home and get transferred to the place of work.</div><div><br></div><div>In the light of the above, it is imperative that the focus shift from personnel hygiene to personal hygiene. If the person becomes neat, clean and orderly, then it is relatively easy to train and cultivate a neat, clean and orderly workforce.</div><div><br></div><div>Moreover, a human being is a creature of habits. Habits are formed by the repetition of actions over a considerable period of time. This requires discipline and monitoring. This technique can also erase old bad habits and cultivate new good habits.</div><div><br></div><div>What exactly is personal hygiene?</div><div><br></div><div>Besides looking and smelling good, personal hygiene is about prevention of diseases and maintaining good health over the life span.</div><div><br></div><div>We begin our day by brushing our teeth. Are we consistent with our brushing? Do we do the actions of brushing in a carefully designed and defined manner? Do we reach all corners of the mouth and access all teeth? Do we favour a particular side while brushing? Do we clean our tongue? </div><div><br></div><div>Importantly, are we conscious of brushing while brushing? Many of us brush our teeth while thinking of something else. Sometimes we are in such a hurry that brushing is cursorily done. The fad of multitasking has also led us to be thinking of something else while our hands are engaged in an entirely unrelated activity.</div><div><br></div><div>Do we plan our oral hygiene program? Is there a dentist visit included in our program? Do we use dental floss or mouth rinses? How often do we rinse our mouth? Do we do so after each meal? The modern world influenced by different cultures seems to be shunning the old habit of rinsing the mouth. It is considered cool to be able to use a tissue 'appropriately' to wipe the mouth and it is a matter of etiquette how adept you are at using the finger bowl. But these do nothing for your oral hygiene.</div><div><br></div><div>Bad breath is usually associated with bad oral hygiene. Bad breath can happen with food particles lodged and decaying in the mouth especially teeth. While it may be true to an extent, bad breath usually comes from deep within your food passages. It reflects poor food habits and bowel movement and when air from the respiratory system accompanies the odour from the gastric system, it is termed as bad breath. Consumption of onion and garlic is a good example of breath coming from within the gastric system. </div><div><br></div><div>One can really run an intensive and elaborate training program about brushing teeth.and oral hygiene because the mouth is a huge source of microorganisms and a human being is the largest contributor to the microbial load in a pharmaceutical manufacturing environment. The quantum of bioburden can be reduced significantly if the workforce is especially trained in oral hygiene.</div><div><br></div><div>The other area of personal hygiene is the skin and this brings us to the issue of bath, hand wash and toilet practices. The human body has its fair quota of crevices. These are areas of moisture retention and microbial growth. These are also areas of skin irritation and itching which leads the hands naturally to those areas for scratching. Quite obviously the microbial load gets transferred to the fingers and this then gets transferred to the products. </div><div><br></div><div>Having a clean bath is a skill that has to be deliberately acquired by repeated and good bathing practices. Many of us who are hard pressed in the morning due to the time crunch and experiences of delay usually compromise on personal hygiene practices by 'rushing' through the morning processes. </div><div><br></div><div>At the place of work, hand washing stations are not available like trash cans or spittoons all over the campus. Only in the process of change rooms does a person has an opportunity of washing or disinfecting hands. Herein lies the difficulty! It is largely up to the individual to wash or disinfect his hands based on the Standard Operating Procedures displayed in words and picture forms in the change rooms. The personal habits of people come into play. Some do it, some don't and some do it in such a way that it would make good starting material for a stand-up comedian.</div><div><br></div><div>The feet are the biggest carriers of contamination. Shoe covers and booties are actually an eye wash. They look good! When a foot falls on a shoe cover the pressure of the weight of the individual squeezes micro particles through the fabric of the shoe cover. The cleanliness of the foot is again a matter pf personal hygiene. Habits at home come to work. If a person is accustomed to reaching home, tired and in low spirits and simply plonks on the chair or sofa after discarding his footwear, he will carry that same mentality to his place of work. Attention to the cleanliness of feet is a distant matter. To think about it, the foot is at the furthest distance from our thinking apparatus, the brain.</div><div><br></div><div>Then there is this small matter of fingernails and the gap under them. Great assembly halls for microbes to have a ball. Literally! Cutting nails is another personal hygiene issue cultivated by practice. Also a trifle difficult subject when it comes to ladies as fingernails is a fashion statement. Then there is the other aspect of nail polish and artificial nails.</div><div><br></div><div>The ears, nose, hair, armpits, pelvic area are other areas for care and personal hygiene with particular attention.</div><div><br></div><div>It is actually a subject for R&D if it can formulate a program to find out "what" type of contamination comes from "which" part of the body and "when" is the load at its peak and "how" to address this contamination. All GMP guidelines acknowledge the human element as the biggest source of contamination and it is indeed ironical that a minimal effort goes into the aspect of personal hygiene. </div><div><br></div><div>By calling it Personnel Hygiene, the subject is transferred to HR Department and unfortunately the HR is least qualified technically to address this issue and the technical departments are least interested because it is a matter related to HR. Net result: Hygiene continues to languish at the bottom of the attention radar and a lot of focus and effort is on cleaning and cleaning validation.</div><div><br></div><div>One day the focus will hopefully shift to the human factor and due importance will be given to "Personal Hygiene".<br><div class="gmail_signature"><div dir="ltr"> <div><br><a href="mailto:pmanker2005@yahoo.com" target="_blank"></a></div></div></div> </div></div> Pharma Supporthttp://www.blogger.com/profile/04576451206344989281noreply@blogger.com0tag:blogger.com,1999:blog-9201308788041016721.post-47939113452915357392015-04-28T18:05:00.001+05:302015-04-28T18:05:31.197+05:30EU GMP Vol 4 Part 1 Chapter 2<div dir="ltr"><h3 class="" itemprop="name" style="margin:0px;font-weight:normal;font-stretch:normal;font-size:22px;font-family:Arial,Tahoma,Helvetica,FreeSans,sans-serif;color:rgb(244,141,29)"><b style="color:rgb(78,40,0);font-size:13px;line-height:18.2000007629395px"><u>TRAINING</u></b><br></h3><div class="" id="post-body-6619271336281381583" itemprop="description articleBody" style="width:506px;line-height:18.2000007629395px;color:rgb(78,40,0);font-family:Arial,Tahoma,Helvetica,FreeSans,sans-serif;font-size:13px"><div dir="ltr"><div><div><b><br></b></div><div><b>"2.10</b> <i>The manufacturer should provide training for all the personnel whose duties take them into production and storage areas or into control laboratories (including the technical, maintenance and cleaning personnel), and for other personnel whose activities could affect </i><i style="line-height:18.2000007629395px">the quality of the product</i><span style="line-height:18.2000007629395px">."</span></div></div><div><br></div><div>Training is generally considered a Human Resource Department function. That could be as it should be from the organization's point of view but it is more relevant to the department concerned with an employee within its folds. </div><div><br></div><div>So, what is training?</div><div><font face="arial, helvetica, sans-serif"><br></font></div><div><font face="arial, helvetica, sans-serif"><span style="color:rgb(0,0,0);line-height:26.3999996185303px">Training and development describes the formal, ongoing efforts of organizations to improve the performance and self-fulfillment of their employees through a variety of </span><span style="color:rgb(0,0,0);line-height:26.3999996185303px">methods and programs.</span><span style="color:rgb(0,0,0);line-height:26.3999996185303px"><br> <a href="http://www.referenceforbusiness.com/small/Sm-Z/Training-and-Development.html#ixzz3YZd9Gi8A" style="text-decoration:none;color:rgb(0,51,153);border-bottom-width:1px;border-bottom-style:dotted;border-bottom-color:rgb(103,169,193)">http://www.referenceforbusiness.com/small/Sm-Z/Training-and-Development.html</a></span></font><br></div><div><br></div><div>The key words are "formal" and "ongoing". While most organizations achieve the objective of "formal" because auditors insist on checking training records, the ongoing training is an issue. </div><div><br></div><div>Let us explore the circumstances that guide the training policies and philosophies:</div><div><br></div><div><b>In-house training</b> is the most popular. While this will be the most relevant training module as it deals with the subject matter with reference to context, it has some in-built short-comings.</div><div><br></div><div>a. Availability of a skillful trainer is a difficulty with most organizations. </div><div>b. Availability of time for the trainer and the trainees since both belong to the same set-up and have their job descriptions crystallized, the job priorities pulls them away from training and justice is not done to training.</div><div>c. Existence of power pulls due to superior and subordinate hierarchy.</div><div>d. Focus shift as familiar background and urgency of matters will tend to drag the discussions out of context and the focus would shift from the topic in hand to the topic burning on the floor.</div><div>e. Interference of inter-departmental rivalry and depends on presence of dominant personalities or numbers</div><div>f. The age old syndrome of what is in-house is not good enough. The grass is always greener across the borders.</div><div><br></div><div>External Training is perhaps better received because of lack of familiarity with the trainer and a new outlook towards the subject as the perspective of the external trainer will be refreshingly different from that of those within the organization. But external training can be fraught with the following dangers:</div><div><br></div><div>a. There is a possibility of a mismatch between what the trainer wants to teach and what the organization and its individuals want to learn if the initial groundwork is slipshod.</div><div>b. The external trainer's knowledge and experience may be questionable</div><div>c. The context of the trainer might not be relevant to the trainees. For example a trainer from a formulations background would use that context which may not be wholly understood by the trainees from API background</div><div>d. There is a communication gap or failure of communication between the trainer and the trainees due to unfamiliarity.</div><div>e. The trainer may not be allowed access to the trainees' facilities in tune with company policy. This makes the job of the external trainer that much difficult as he is not in a position to tailor the training to the context of the trainees.</div><div>f. Cost of the external trainer may be an unbudgeted issue and hence always easy to axe the training itself.</div><div><br></div><div>In both cases, internal or external, the unstinted support and commitment of the top management is absolutely essential. It is very easy to convert a training program to a farce. Mere classroom training is 50% of the job done. On-the-job training, whether done by the internal trainer or the external trainer, is an absolute must. Real knowledge comes from actual practice. Theoretical knowledge is cramming of information and it tends to evaporate rather quickly. Things done physically or practically tend to stick and the finer nuances of the job can best be demonstrated in practical training.</div><div><br></div><div><b>"2.11</b> <i>Besides the basic training on the theory and practice of the quality management system and Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed. Training programmes should be available, approved by either the head of Production or the head of Quality Control, as appropriate. Training records should be kept</i>."</div><div><br></div><div>Newly recruited persons, especially those coming directly from Universities with no industrial experience come with a baggage. A human being is not a machine to be switched on and off. Whoever the person is in his personal life, it is the same person who walks in to work. For example, an undisciplined individual person at home will be more difficult to discipline and made to fall in line with the organizational needs than a disciplined person in his personal life. Moreover, University life is vastly different. There is glamour, bravado, show-off opportunities and a little bit of anit-establishment atmosphere, which is considered 'cool'. All these are detrimental in the industry and take quite some time to erase. </div><div><br></div><div>The induction program and the probationary period are crucial times for a new entrant and it is here that many companies are found wanting. Attaching a fresh recruit to an experienced guy is not the best form of training and induction. Especially if this combination is not monitored.</div><div><br></div><div>Refresher training programs are generally not done and whenever undertaken, there is a feeling of "so what's new?" in the whole approach. Here the skill lies in designing the program and the power and skill of the facilitator or speaker plays a vital role. Most companies miss out on this front. I suspect that the major reason is that such training programs are conceptualized mostly to fulfil regulatory needs more than knowledge or skill needs.</div><div><br></div><div>There is more to training considerations than what has appeared here. This is just a brain teaser for people to sink their teeth into and mull over. There is a huge gap in what the regulatory guidelines say and what is the actual need in the industry. Lot of what is required is unsaid in the guidelines as it is impossible to cover all practical aspects in guidelines. It is for the industry captains to wake up and give training the due importance. </div><div><br></div><div>The results of lack of training are there for all to see!</div></div></div></div> Pharma Supporthttp://www.blogger.com/profile/04576451206344989281noreply@blogger.com0tag:blogger.com,1999:blog-9201308788041016721.post-33542183380430611512015-04-16T18:42:00.000+05:302015-04-16T18:44:15.088+05:30CAPA TRAINING - Jubilant Generics, Nanjangud<p class="mobile-photo"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg_4UntEFXEK8OwULuCvqANkeZr84LS1tc9GqRNT-RHJCJKWWRGHjjipn1Rf2mCjPnvA3XFWaBEY8o2d1D9tDFjuEIiJVqDr9fnexohXaOU-qYbaBSdQaoE-UduZt0sWApx-05ojS5-iCA/s1600/PicsArt_16_04_2015+18_34_10-755089.jpg"><img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg_4UntEFXEK8OwULuCvqANkeZr84LS1tc9GqRNT-RHJCJKWWRGHjjipn1Rf2mCjPnvA3XFWaBEY8o2d1D9tDFjuEIiJVqDr9fnexohXaOU-qYbaBSdQaoE-UduZt0sWApx-05ojS5-iCA/s320/PicsArt_16_04_2015+18_34_10-755089.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_6138324549339968162" /></a></p><p class="mobile-photo"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjgSnVXdn7sAqLhGKgOIstnc02jRTmlk2qs1j1KUZmBU1bUkFHH1ExSWNCSkERg5XIpYr8ULEiiAXxBLRphGVh2-0auVR36Oz-9DgKe4g4U5uemkLswSJQ73GmOcx7uYSSjRhd3spmK1Qo/s1600/PicsArt_16_04_2015+18_35_57-758892.jpg"><img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjgSnVXdn7sAqLhGKgOIstnc02jRTmlk2qs1j1KUZmBU1bUkFHH1ExSWNCSkERg5XIpYr8ULEiiAXxBLRphGVh2-0auVR36Oz-9DgKe4g4U5uemkLswSJQ73GmOcx7uYSSjRhd3spmK1Qo/s320/PicsArt_16_04_2015+18_35_57-758892.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_6138324564737157042" /></a></p><div><div style="font-family: Calibri,sans-serif; font-size: 11pt;">A two-days workshop conducted at The Quorum Hotel, Mysore on CAPA for the Senior Technical Staff of Jubilant Generics, Nanjangud on 15th and 16th April, 2015.</div></div>Pharma Supporthttp://www.blogger.com/profile/04576451206344989281noreply@blogger.com0tag:blogger.com,1999:blog-9201308788041016721.post-60028885499387884132015-04-08T12:49:00.001+05:302015-04-08T12:49:48.816+05:30How many levels of cGMP do we have?<div dir="ltr"><span style="font-size:12.8000001907349px">The Pharmaceutical Industry is regulated because the government is answerable to its citizens in case of health issues. Current Good Manufacturing Practices, cGMP for short, is a regulatory tool that prescribes certain code of conduct for manufacturers of healthcare products. Upon inspection and satisfactory compliance with prescribed norms, a manufacturer is allowed to manufacture and sell his products in the market which falls under the jurisdiction of the government.</span><div style="font-size:12.8000001907349px"><br></div><div style="font-size:12.8000001907349px">However, even a cursory look at the practices adopted by manufacturers in the country reveals multiplicity of standards. This would make one wonder if human life is equal or graded on several platforms.</div><div style="font-size:12.8000001907349px"><br></div><div style="font-size:12.8000001907349px">The most obvious platform is <b><u>Purchasing Power</u></b>, which in common parlance would translate to affordability. If I can afford it, I will buy a product of a reputed organization even if it is priced way ahead of some of the similar products. This is best exemplified by the tea that we drink as a national drink. Tea is available at a road-side stall, in a Grade II restaurant, in branded franchise outlets and in Five-Star establishments. The price can vary from Rupees 3 to Rupees 300. What is the customer paying for? Obviously the quality of ingredients, manufacturing environment (read kitchen), ambiance, cleanliness of equipment for making and serving, cleanliness of the individuals involved in the process. You can easily visualize the manufacturing and service at the roadside stall. One would expect a superior condition in the higher establishments.</div><div style="font-size:12.8000001907349px"><br></div><div style="font-size:12.8000001907349px">Coming back to healthcare products, the matter is a little more sensitive. The person consuming these products does not do so by choice but because he is prescribed to do so because of certain diseased condition. Quite obviously, he is in a weakened state of health and one would expect a safe quality of product reaching such an individual. </div><div style="font-size:12.8000001907349px"><br></div><div style="font-size:12.8000001907349px">If this is the case, then all products manufactured in the country should be uniformly acceptable to the world. Herein lies the glitch. We have manufacturers qualified to market products in the developed countries typified by the USA, European and the Japanese markets. This means that those manufacturers who are not qualified are automatically disallowed. This raises the question of equality of human beings. Are Indian citizens lesser human beings than those in the developed worlds that they are given products from companies not qualified by the drug regulating agencies of the developed world?</div><div style="font-size:12.8000001907349px"><br></div><div style="font-size:12.8000001907349px">Then we have what is popularly known as qualification by the World Health Organization (WHO). But companies qualified by the WHO are not permitted to sell their products in the developed market because they are not qualified by the regulators of the developed world. This raises a question about the validity of a WHO certificate. Is the World Health Organization not recognized by the countries of the so called developed world? Then the WHO should be renamed as UWHO which would stand for Under-developed World Health Organization. But this again raises the question of equality of human beings. Are the people of the Africa and Asian continent (except Japan) lesser humans or should we say lesser quality humans?</div><div style="font-size:12.8000001907349px"><br></div><div style="font-size:12.8000001907349px">Then we have different countries sending their regulators to inspect and certify Indian establishments. This is a clear indication that there is no uniformity in the world about standards of healthcare products or there is no trust in the WHO certification even by regulators of under-developed countries. This can be perhaps understood because each government of every country would like to show its citizens that they are doing their bit in buying products after due qualification.</div><div style="font-size:12.8000001907349px"><br></div><div style="font-size:12.8000001907349px">But if we talk of the Indian context, then within the same government we have varying tolerances. Every State has its own Food and Drug Administration (FDA) and the qualification criteria followed by one State need not necessarily meet the qualification criteria of another. Some States are more lenient in the interpretation of the Law while some States have other considerations in looking the other way.While Schedule M is compulsory all over India, companies in some States observe it cursorily and others observe it more stringently. </div><div style="font-size:12.8000001907349px"><br></div><div style="font-size:12.8000001907349px">Coming to one State for example, we will also find multiplicity of standards. We have MNCs, Indian MNCs, Medium Scale and Small Scale manufacturers occupying a piece of the lucrative healthcare pie. Each one has a certificate for manufacturing and selling. Some have properly designed and constructed factories. The small scale manufacturer is housed in an Industrial gala and has manipulated, twisted, bent and stretched the law in an attempt to qualify for a licence. One can understand the need for low cost products to cater to all strata of society. What one fails to understand is that a human body and its organs do not recognize costs. They recognize quality. The compromise is so huge that one wonders if cGMP for the poor class, the lower middle class, the upper middle class, the rich class and the super rich class can be different. The next question naturally would relate to the type of heart or lungs or liver or pancreas each category possesses. Would like a medical opinion on the gradation of the human organs based on economic classification of our society.</div><div style="font-size:12.8000001907349px"><br></div><div style="font-size:12.8000001907349px">Now consider this! If you are consuming products orally, you have some natural protection of your digestive tract which filters away rubbish. Imagine what must be happening when you take intravenous injections that by-pass the defense mechanism of the body and enters the blood directly. You are literally at the mercy of the condition of manufacture of the small scale establishment.</div><div style="font-size:12.8000001907349px"><br></div><div style="font-size:12.8000001907349px">Also, the pay scales being so diversely different, the kind of qualification, knowledge and experience in the lesser establishment would leave a lot to be desired. Some of the staff are not conversant with English and all the laws and guidelines are written in English. So, we now have a heady cocktail of</div><div style="font-size:12.8000001907349px">the industrial gala, the matchbox factory, the medium-scale unit, the Indian ownership unit, the Indian MNC and the foreign MNC and their various levels of cGMP. Within a company we can have an export quality product for the developed countries, an export quality product for the WHO qualified countries, a product for the high end local market qualified by the Indian regulator, a product manufactured in a small-scale unit on contract manufacturing basis for the lower end market and finally some other manufacturing standard for the government hospitals. Who loses? Obviously the citizen who opts for the relatively "cheaper" product. All, of course, qualified by the elected government! </div><div style="font-size:12.8000001907349px"><br></div><div style="font-size:12.8000001907349px">Think about it!!!</div><div><br></div><div class="gmail_signature"><div dir="ltr"> <div><br><a href="mailto:pmanker2005@yahoo.com" target="_blank"></a></div></div></div> </div> Pharma Supporthttp://www.blogger.com/profile/04576451206344989281noreply@blogger.com0tag:blogger.com,1999:blog-9201308788041016721.post-41808108772952546432015-04-01T23:36:00.001+05:302015-04-01T23:36:30.371+05:30CAPA<p class="mobile-photo"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjkuEM_XUL9dBLoaVJN2FeUWYC70buW_AN3HnXyY3fJZ1R2N1CG2afSVFOEuUIITQtUm2bbESvZtxQTw6v-oxjQhndYDvkNfXOkFxfvADwdGXSR4svI5WXLAo1dwGWlJkvqRsMEQLcdT3s/s1600/WP_20150401_23_26_03_Pro-790372.jpg"><img src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjkuEM_XUL9dBLoaVJN2FeUWYC70buW_AN3HnXyY3fJZ1R2N1CG2afSVFOEuUIITQtUm2bbESvZtxQTw6v-oxjQhndYDvkNfXOkFxfvADwdGXSR4svI5WXLAo1dwGWlJkvqRsMEQLcdT3s/s320/WP_20150401_23_26_03_Pro-790372.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_6132833583481518082" /></a></p><div><div style="font-family: Calibri,sans-serif; font-size: 11pt;">Corrective Action, Preventive Action is successful if Investigation is exhaustive and Root Cause Analysis (RCA) is accurate. <br>Usually the root cause is very near the point of deviation but most of us focus at the point of impact or incidence of failure.</div></div>Pharma Supporthttp://www.blogger.com/profile/04576451206344989281noreply@blogger.com0tag:blogger.com,1999:blog-9201308788041016721.post-60838691089199440222015-01-27T13:43:00.001+05:302015-01-27T13:43:46.847+05:30CAPA<div dir="ltr"><div><div>Should all deviations be logged into one CAPA register or should there be separate tracks for "Incidence", "Market Complaints", "Deviations" and "Batch Failures"?<br><br></div>What is the practice in India?<br><br></div>What is the expectation of the regulated market administrators?<br></div> Pharma Supporthttp://www.blogger.com/profile/04576451206344989281noreply@blogger.com0tag:blogger.com,1999:blog-9201308788041016721.post-62285035282279520892015-01-19T15:31:00.001+05:302015-01-19T15:31:02.782+05:30cGMP<div dir="ltr">GMP is all about PEOPLE and how they behave while manufacturing and testing medicines. AGREE / DISAGREE<br clear="all"><div><br></div>-- <br><div class="gmail_signature"><div dir="ltr"><div>Pravin Manker<br>Cell: +919870052022</div> <div></div> <div>Skype: pravin.manker2</div> <div><br><a href="mailto:pmanker2005@yahoo.com" target="_blank"></a></div></div></div> </div> Pharma Supporthttp://www.blogger.com/profile/04576451206344989281noreply@blogger.com0