Monday, July 6, 2009

FDA GMP - Tips on Penicillin Drugs

Updated Aug 18, 2016:
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)

- -  original post follows below  - -
Here's a little refresher in the form of 4 questions, answered by the FDA, Questions and Answers on Good Manufacturing Practices Questions and Answers on Good Manufacturing Practices - Penicillin Drugs.

In a nutshell, all penicillin finished pharmaceutical manufacturers, including repackers, are required by the CGMP regulations to establish a comprehensive control strategy designed to prevent cross-contamination of other drugs with penicillin. These requirements include:

  • 21 CFR 211.42(d): Separation of facility and equipment
  • 21 CFR 211.46(d): Separate air handling systems (HVAC)
  • 21 CFR 211.176: Test for traces of penicillin where possible exposure exits.
Related Posts:
2009 FDA Orange Book Online - Brand New 29th Edition
Easy FDA Orange Book Search Widget
About The FDA Orange Book - Slide Deck (free)
FDA Orange Book - Online
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