GUIDANCE FOR INDUSTRY QUALITY SYSTEMS APPROACH TO PHARMACEUTICAL CGMP REGULATIONS

This guidance is intended to help manufacturers implementing modern 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. Implementation of a comprehensive quality systems model for human and veterinary pharmaceutical products, including biological products, will facilitate compliance with 21 CFR parts 210 and 211. The central goal of a quality system is the consistent production of safe and effective products and ensuring that these activities are sustainable. Quality professionals are aware that good intentions alone will not ensure good products. A robust quality system will promote process consistency by integrating effective knowledge-building mechanisms into daily operational decisions. Both good manufacturing practice and good business practice require a robust quality system. When fully developed and effectively managed, a quality system will lead to consistent, predictable processes that ensure that pharmaceuticals are safe, effective, and available for the consumer.

Key words: Guidance, Industry, Quality Systems, Pharmaceutical CGMP Regulations