FDA GMP - Tips on Penicillin Drugs

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.

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