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.
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
Posts
No comments:
Post a Comment