The Essential Guide to Combination Products cGMPs

AnaMariaVR2

AnaMariaVR2

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According to FDA, this ruling will affect every combination product?and not a single one is ?grandfathered.?
They require you not only to review your manufacturing procedures?particularly when different constituent parts are made at separate facilities?but also to:
- Review and/or modify SOPs
- Review and/or modify QC/QA systems
- Institute new employee training programs and protocols
- Make top-to-bottom reviews of dozens of internal processes


A Final Rule on current Good Manufacturing Practice Requirements for Combination Products was published in the Federal Register Jan. 22, 2013.

Current Good Manufacturing Practice Requirements for Combination Products

Federal Register - Current Good Manufacturing Practice Requirements for Combination Products
 
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