Implementing A Systemic Approach To Pharmaceutical Quality Systems

By Christine Park, Quality Architech

In 2002, the Food and Drug Administration (FDA) announced an initiative to integrate quality systems and risk management approaches into existing regulations for pharmaceutical manufacturing. While the FDA hasn’t changed the 21 Code of Federal Regulations (CFR) Parts 210 and/or 211 regulations, they have published industry guidance, Quality Systems Approach to Pharmaceutical CGMP Regulations.

In addition, the International Conference for Harmonization (ICH) issued the Q10 Guideline, which describes a model for the implementation of an effective quality management system for the pharmaceutical industry. This guidance integrates key current Good Manufacturing Practice (cGMP) concepts from the pharmaceutical industry with risk management principles, and sets the stage for a systemic approach to pharmaceutical development and manufacturing.