Pharmaceutical Quality Systems

Myth: The elements of ICH Q10 Pharmaceutical Quality System (PQS) conflict with good manufacturing practices (GMPs) and the International Organization for Standardization's (ISO) quality management systems.

Reality: They really work together and augment each other. There are certain areas that GMPs don't specifically mention or if they are implicit, Q10 brings them out. What we have announced in the US Food and Drug Administration is an incremental approach to updating our GMPs, not a wholesale change of them. As shown in the ICH Q10 PQS model, GMPs are to be used in conjunction with the pharmaceutical quality system (PQS)....[the diagram] puts in place a way to follow GMPs and to have more holistic coverage because GMPs have always been represented as a minimal standard. ISO 9001 and Six Sigma principles are also consistent with the Q10 document. The important thing to keep in mind is that Q10 was written for pharmaceutical products. —Joseph C. Famulare, deputy director of the Center for Drug Evaluation and Research, FDA