This guidance is intended to help manufacturers implementing mode rn quality systems and risk management approaches to meet the requirements of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211). The 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. The guidance also explains how manufacturers implementing such quality systems can be in full compliance with parts 210 and 211. This guidance is not intended to place new expectations on manufacturers, nor to replace the CGMP requirements. Readers are advised to always refer to parts 210 and 211 to ensure full compliance with the regulations.


This guidance describes a comprehensive quality systems model, which, if implemented, will allow manufacturers to support and sustain robust, modern quality systems that are consistent with CGMP regulations. The guidance demonstrates how and where the elements of this comprehensive model can fit within the requirements of the CGMP regulations. The inherent flexibility of the CGMP regulations should enable manufacturers to implement a quality system in a form that is appropriate for their specific operations.