FDA Publishes New Q-and-A on cGMP for Penicillin Drugs

As part of the "Questions and Answers on Good Manufacturing Practices Good Guidance Practices", FDA published a new section on penicillin drugs. FDA's Q&A on cGMP is a helpful source of information. The FDA is publishing answers on frequently asked questions in this level-2 guidance. On 29 June 2009 the following information was published:

Is cross-contamination a concern with penicillin drugs?

Yes, penicillin can be a sensitizing agent that triggers a hypersensitive exaggerated allergic immune response in some people. Differences in the chemically substituted 6-aminopenicillanic side chain can generate allergic reactions ranging from skin rashes to life-threatening anaphylaxis.

Are there special manufacturing requirements for penicillin drugs?

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 exits.

Penicillin containing 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 International Conference on Harmonization (ICH) Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. Chapter 4, section 4.4 of this guidance describes actions API manufacturers, including those who manufacture or package APIs or penicillin intermediates, are to follow to ensure such material is contained and does not contaminate other drugs.

References:
1. Yao, Joseph D. C., and Robert C. Moellering, Jr. "Antibacterial Agents." Manual of Clinical Microbiology. 9th ed. Washington D.C., ASM, 2007
2. FDA CGMP regulations (21 C.F.R. Parts 210-211)
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm095412.htm
3. The Federal Food, Drug, & Cosmetic Act 501(a)(2)(B)
http://www.fda.gov/RegulatoryInformation/Legislation/ FederalFoodDrugandCosmeticActFDCAct/default.htm
Contact for further information:
Edwin Melendez, Consumer Safety Officer
CDER/OC/

Source: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM169670.pdf

 

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