Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations

Overview:

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.

This content is available to logged in users.

Author: FDA Center for Drug Evaluation and Reseacb  | File Type: PDF

Find more white papers on Process OperationsFacilities & SupportIndustry DevelopmentsFacilty Design & Management

View all white papers»