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

J&J Speeds Ebola Vaccine Development and Expands Production
October 24, 2014
Despite AbbVie Snub, Shire Says it Will Double Sales by 2020
October 24, 2014
Manufacturing Challenges of mAb Production: CHO or Plant Cells?
October 24, 2014
Celgene and Sutro Partner on ADC Development
October 24, 2014
GSK Accelerates Ebola Vaccine Development
October 24, 2014
Author Guidelines

Click here