FDA Releases Guidance on Non-Penicillin Beta-Lactam Drugs - - BioPharm International

ADVERTISEMENT

FDA Releases Guidance on Non-Penicillin Beta-Lactam Drugs


FDA has released Guidance for Industry: Non-Penicillin Beta-Lactam Drugs:
A CGMP Framework for Preventing Cross-Contamination. In the guidance, FDA stresses the importance of implementing manufacturing controls to prevent cross-contamination of finished pharmaceuticals and APIs with non-penicillin beta-lactam drugs. FDA also provides information regarding the relative health risk of cross-reactivity in the classes of sensitizing beta-lactams (including both penicillin and non-penicillin beta-lactams). FDA states that manufacturers generally should use separate facilities for the manufacture of non-penicillin beta-lactams because those compounds pose health risks associated with cross-reactivity.

According to FDA, penicillin can be a sensitizing agent that triggers a hypersensitive exaggerated allergic immune response in some people. FDA, therefore, points out that implementing methods for preventing cross-contamination of other drugs with penicillin is a key element of manufacturing penicillin and CGMP regulations require the use of such methods.

FDA also states that non-penicillin beta-lactam drugs also may be sensitizing agents and cross-contamination with non-penicillin beta-lactam drugs can initiate the same types of drug-induced hypersensitivity reactions that penicillin can trigger, including life-threatening allergic reactions. Manufacturers of non-penicillin beta-lactam drugs, therefore, should use similar control strategies to prevent cross-contamination.

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Baxter Initiates Voluntary Recall of Potassium Chloride Injection
September 17, 2014
PDA Announces Technical Report on Drug Shortages
September 9, 2014
European Commission Approves RoACTEMRA for Treatment of RA
September 9, 2014
FDA Releases Guidance Electronic Submission of Lot Distribution Reports
September 5, 2014
Infinity and AbbVie Collaborate to Develop Oncology Drug
September 5, 2014
Author Guidelines

Click here