Yes, 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 exists.
Penicillin active pharmaceutical ingredients (APIs) are also required to be manufactured under CGMPs in accordance with section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. FDA has published internationally harmonized guidance on the manufacture of APIs; see ICH guidance for industry, Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. Chapter 4, section 4.4 of this guidance describes actions API manufacturers, including those that manufacture or package APIs or penicillin intermediates, are to follow to ensure such material is contained and does not contaminate other drugs.
