As part of the Current Good Manufacturing Practices (CGMP) initiative announced in August of 2002, and to help FDA be more transparent with CGMP policy, we have developed this question and answer resource on current good manufacturing practices. We intend to use this format to provide timely answers to questions about the meaning and application of CGMPs for human, animal, and biological drugs, and to share these widely. These questions and answers clarify statements of existing requirements or policy that are minor in nature, and as such, are considered Level 2 guidance. You may submit comments on this guidance at any time. Submit comments to Docket No. FDA-2017-D-6821 (see the instructions for submitting comments in the docket). This resource is being cosponsored by CDER, CVM, CBER, and ORA. The Q&As generally clarify the existing CGMP regulations for finished pharmaceuticals: 21 CFR part 211

Questions and Answers on Specific Topics:

• General Provisions
• Organization and Personnel
• Buildings and Facilities 
• Equipment  
• Control of Components and Drug Product Containers and Closures
• Production and Process Controls 
• Packaging and Labeling Control
• Holding and Distribution 
• Laboratory Controls
• Records and Reports
• Returned and Salvaged Drug Products 

 

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Contact for Further Information:

CDER-OPQ-Inquiries@fda.hhs.gov

 

Home | General Provisions | Buildings and Facilities | Equipment | Control of Components and Drug Product Containers and Closures | Production and Process Controls | Holding and Distribution | Laboratory Controls | Records and Reports | Returned and Salvaged Drug Products