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Small and Medium Pharmaceutical Industry Centre (SMPIC) aims at creating synergy between industry and academia. The centre was setup to develop and assist SME pharma units to meet global challenges in regulatory requirements, Good laboratory practices and schedule M. The centre organizes seminars on issues related to GLP, GMP and other allied areas. In this series, a one day seminar on 'Documentation Requirements For Regulatory Compliance' was organized on 6th April, 2017. The seminar provided an insight into the documentation requirements for regulatory compliance for export of pharmaceuticals. Topics like Qualification and Validation Principles, Process validation, analytical method development, stability studies of Pharmaceutical products and Water Systems in Pharmaceutical industry were discussed in length by the experts. Eminent personalities from regulatory agencies (Dr. Naresh Sharma, Assistant Drugs Controller (India), CDSCO, DGHS, MoHFW, India) and highly experienced personnel from pharmaceutical industry (Mr. D R Panda, GM, QA, Glenmark Pharmaceuticals Ltd., Baddi and Mr. A P Gupta, AGM Retd., SunPharma Ltd., Mohali Retd.) delivered lectures at the forum. The seminar was well attended by about 50 personnel from industry and students from various institutes. The participants got an opportunity to learn and enhance their knowledge on preparation of documents as per regulatory requirements on above topics at various stages of production of a drug molecule or API. |
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| Page Uploaded/Updated on 10-April-2017 |