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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…
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…
Any generic industry thrives on defects reduction, increasing productivity, quality improvement, cost reduction, continual improvement etc. There are various principles or methods available, which helps to achieve our aim of Lean Manufacturing Procedures and Good Manufacturing Practices. We all know…
In the previous article entitled Critical Process Parameters (CPP) – What’s the Buzz, we had built an understanding regarding Critical Process Parameters and how their identification and selection is based on Critical Quality Attributes (CQAs) among many other factors. Any…