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May 5, 2020 Manufacturing Quality Branch (MQB), Therapeutic Goods Administration (TGA), Australia has notified that they are intending to adopt the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE009-14) issued, 1 July 2018, as…
As per ICH Q9 “Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quality of the product throughout its life cycle.” There are many methods and tools to perform Quality Risk…
As per ICH Q9 “Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quality of the product throughout its life cycle.” There are many methods and tools to perform Quality Risk…
May 1, 2020 Central Drugs Standard Control Organization (CDSCO), the Government of India Drug Regulatory Agency has extended the validity of WHO GMP/ Certificate of Pharmaceutical Product (COPP) expiring from March 2020 to August 2020 by six months from…
April 30, 2020 Glenmark Pharmaceuticals announced that it has received the Drugs Controller General (I) permission to conduct clinical trial on Favipiravir. As on date, Glenmark is the first pharmaceutical company in India to be given an approval by…