By Emily Krulewitz
In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative, which explained FDA’s intent of integrating quality systems and risk management approaches, and had a goal of encouraging industry to adopt modern and innovative manufacturing technologies. This initiative was driven by the fact that it had been 24 years since the Agency made its last major revision to CGMP regulations. This 21st Century Initiative created a Quality System Guidance Development working group (QS working group) to compare the current CGMP to other existing quality management system. This QS working group realized that the CGMP regulations do not explicitly incorporate all of the elements that today constitute most quality management systems. Therefore, the QS working group decided that it would be useful to examine exactly how the CGMP regulations and the elements of a modern, comprehensive quality system fit together in today’s manufacturing world. The product of this examination is the September 2006 “Guidance For Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations.”
This guidance describes a comprehensive quality systems (QS) model, highlighting the model’s consistency with the CGMP regulatory requirements for manufacturing human and veterinary drugs, including biological drug products. This guidance also explains how manufacturers implementing such quality systems can be in full compliance with 21 CFR parts 210 and 211. This guidance is important because it helps bridge between the 1978 regulations and the Agency’s current understanding of quality systems. The guidance is intended to help manufacturers implementing modern quality systems and risk management approaches to meet the requirements of the Agency’s CGMP regulations.
The guidance reviews CGMPs and some concepts of modern quality systems including: quality; quality by design and product development; quality risk management; CAPA (corrective and preventive action); change control; the quality unit; and six-system inspection model. The guidance then dives into a discussion of the quality systems model, breaking it down into management responsibilities, resources, manufacturing, and evaluation activities. Finally, the guidance provides almost two full pages of useful reference materials and an extensive glossary. This guidance is incredibly comprehensive and is an excellent resource for any quality professional regardless of their level.