Are you manufacturing Non penicillin Beta-lactams? Know FDA expectations on preventing cross contamination.


In April 2013 FDA published guidance on cGMP framework for preventing cross contamination of Non penicillin beta lactams. This guidance describes the importance of implementing manufacturing controls to prevent cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients (APIs) with non-penicillin beta-lactam drugs.This guidance mentions the expectations that manufacturers should utilize separate facilities for the manufacture of non-penicillin beta-lactams because those compounds pose health risks associated with cross-reactivity.

21 CFR 210 mentions the need to prevent cross contamination of penicillin since it cases allergic reactions in patients. It also asks manufacturers to maintain separate air handling units and also asks to monitor levels of penciling in other non-penicillin products manufactured in and around the penicillin manufacturing facilities. April 2013 FDA guidance clarifies 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 penicillins can trigger, including life-threatening allergic reactions. Therefore, manufacturers of non-penicillin beta-lactam drugs should employ similar control strategies to prevent cross-contamination, thereby reducing the potential for drug-induced, life-threatening allergic reactions.
Beta-lactam antibiotics, including penicillins and the non-penicillin classes, share a basic chemical structure that includes a three-carbon, one-nitrogen cyclic amine structure known as the beta-lactam ring.

Beta-lactam antibiotics include the following five classes8:
                        Penicillins (e.g., ampicillin, oxacillin)
                        Cephalosporins (e.g., cephalexin, cefaclor)
                        Penems (e.g., imipenem, meropenem)
                        Carbacephems (e.g., loracarbef)
                        Monobactams (e.g., aztreonam)

The potential health risk to patients indicates that drug  manufacturers should take steps to control for the risk of cross-contamination for all beta-lactam products.

Just as FDA considers the separation of production facilities for penicillins it also  expects manufacturers to treat sensitizing non-penicillin beta-lactam-based products similarly. Specifically, FDA recommends that manufacturers establish appropriate separation and control systems designed to prevent two types of contamination:
1.   The contamination of a non-penicillin beta-lactam by any other non-penicillin beta-lactam, and
2.   The contamination of any other type of product by a non-penicillin beta-lactam.

Accordingly, FDA recommends that the area in which any class of sensitizing beta-lactam is manufactured be separated from areas in which any other products are manufactured, and have an independent air handling system. This control applies to each of the five classes of sensitizing beta-lactams.

At Source consulting we help our customers to respond to FDA observations. For any queries on  non penicillin beta lactam cross contamination, FDA expectations on beta lactam manufacturing facilities, compliance to regulatory inspection for cross contamination related observations Source Consulting team of highly experienced pharma professionals is  always available to help our clients.

For more details you may contact Sourceconsulting team.

01 Jan 2018