7 Takeaways for Pharma from the FDA’s Quality System Guidance

March 3, 2022

Of all the guidances issued by the FDA, the “Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations,” is an essential document for the pharmaceutical industry. The guidance is designed to help drugmakers develop and run good manufacturing practice (GMP) compliant processes. Over the years, the guidance has adapted to meet the industry’s changing conditions and the rise of medical technology. A recent MasterControl article breaks down the 7 takeaways that pharma and biotech firms need to know.

One key concept is “A model that can help pharmaceutical manufacturers comply with CGMP regulations. The six systems referred to in this inspection model are: quality, production, facilities and equipment, laboratory controls, materials, and packaging and labeling.”