What are the CGMP regulations?


Section 501(a)(2)(B) of the Act requires that the methods used in the manufacture, processing, packing, or holding and the facilities used must conform to current good manufacturing practice. The CGMP regulations explain to drug manufacturers what
source: www.fda.gov
Q&A Related to "What are the CGMP regulations?"
The CGMP regulations provide the methods to be used in and the facilities or controls to be used for the manufacturing, processing, packing or holding a drug to assure the drug meets
cGMP stands for Current Good Manufacturing Practices and refers to both written and unwritten regulations that have to be followed when manufacturing, labeling, distributing, transporting
Part 211, subparts I (Laboratory Controls) and J (Records and Reports)
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