Amendment to the cGMP Regulations for Finished Pharmaceuticals

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The FDA is amending certain regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. Amending the regulations will modernize or clarify some of the CGMP requirements, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations.

Click below to access the 7-page amendment.