This resource is being cosponsored by CDER, CVM, CBER, and ORA. Refugees living in northern France say Brexit has made it easier for them to reach the UK in small boats, as it emerged that record numbers of people crossed the Channel in one day. FDA-2017-D-6821 (see the instructions for submitting comments in the docket). You may submit comments on this guidance at any time. These questions and answers clarify statements of existing requirements or policy that are minor in nature, and as such, are considered Level 2 guidance. 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. 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.
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