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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