|
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
Back
to Top
Back to Guidances
Date created: August 4, 2004, updated October 25, 2007 |
|