Questions and Answers on Current Good Manufacturing Practices (CGMP) for Drugs

As part of the 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 generally clarify statements of existing requirements or policy, and as such, are considered Level 2 guidance. This resource is being co-sponsored by CDER, CVM, CBER, and ORA.

Guidance documents represent the Agency's current thinking on a particular subject (21 CFR 10.115). They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternative approach if such approach satisfies the requirements of the application statute, regulations, or both. For more information about a specific guidance document, please contact the originating office.

Current Good Manufacturing Practice for Finished Pharmaceuticals 21 CFR Part 211 (updated 4/1/2010)

• Questions and Answers on Specific Topics

• General Provisions (updated 4/30/2009)
• Organization and Personnel
• Buildings and Facilities (updated 3/12/2010)
• Equipment (updated 5/18/2005) 
• Control of Components and Drug Product Containers and Closures (updated 7/5/2011)
• Production and Process Controls (updated 12/21/2011)
• Packaging and Labeling Control
• Holding and Distribution (updated 8/9/2010)
• Laboratory Controls (updated 7/12/2011)
• Records and Reports (updated 7/19/2011)
• Returned and Salvaged Drug Products (updated 6/24/2011)