Pharmaceutical companies operate in one of the most dynamic environments. Changes in regulations by leading bodies such as US Food and Drug Administration (USFDA) and the European Medicines Agency (EMA) have increased the significance of regulatory compliance management for drug manufacturers. We analysed a total of 155 warning letters issued by FDA's Office of Manufacturing Quality (OMQ) from 2015-2018. The infographic below illustrates the findings.
Cleaning validation has been the most debated compliance topic of the year 2018. Cleaning validation is a critical aspect of GMP and quality control, and is under constant scrutiny by the FDA and other regulatory authorities. cGMPs include the prevention of possible contamination and cross-contamination of APIs and Finished products.
If you are connected to the life sciences industry in one way or another, you have undoubtedly heard of the USFDA’s 21 CFR Part 11 regulation. It applies to systems used in researching, manufacturing, and distributing product such as pharmaceuticals, medical devices, biological products (e.g. vaccines), blood, and tissue (e.g. organ transplants). FDA gave electronic signatures legal equivalence with traditional “wet ink” signatures on paper in 1997.
Non-compliance is the biggest threat to the growth story of the Indian pharmaceutical Industry today. The number of warning letters issued by the FDA has increased drastically since 2016 (chart below).