FDA Releases Guidance on Non-Penicillin Beta-Lactam Drugs - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
30%
Attracting a skilled workforce
27%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
30%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans

Click here