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

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.

Questions and Answers on Current Good Manufacturing Practice for Finished Pharmaceuticals 21 CFR 211
General (updated 6/14/2007)
Organization and Personnel
Buildings and Facilities
Equipment
Control of Components and Drug Product Containers and Closures (updated 10/25/2007)
Production and Process Controls
Packaging and Labeling Control
Holding and Distribution
Laboratory Controls
Records and Reports
Returned and Salvaged Drug Products
Penicillin Drugs

abrir aquí para acceder a los documentos previamente listados:
Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs