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New FDA Guidance for Beta-Lactam Antibiotics facility  

This guidance is intended for manufacturers of finished pharmaceuticals and active pharmaceutical ingredients, including repackagers.

Here FDA recommends that the manufacturing area should be separate for different class of beta-lactams, with independent air handling system.

Like penicillin, non-penicillin beta-lactam drugs can also be sensitizing agents and on cross-contamination, these can trigger hypersensitivity allergic reactions, which may be life-threatening. Therefore, similar control strategy as of penicillin should be employed by the manufacturers of non-penicillin beta-lactam drugs. This guidance recommends establishing separation as well as respective controls to prevent two kinds of cross contamination:

1. The cross contamination between the groups (i.e. contamination of a non-penicillin beta-lactam by any other non-penicillin beta-lactam)

2. The cross contamination between medicinal products in general and a (not-Penicillin) Beta-Lactam Beta-lactam antibiotics include the following five classes: penicillins (e.g., ampicillin, oxacillin); cephalosporins (e.g., cephalexin, cefaclor); penems (e.g., imipenem, meropenem); carbacephems (e.g., loracarbef) and monobactams (e.g., aztreonam). Article 21 CFR 211.42(d), paragraph 211.46(d) and paragraph 211.176 talks about the separate manufacturing, processing and packaging area for penicillin, separate ventilation system and testing of medicinal products for any cross-contamination, respectively.

Now this new FDA guidance covers that how should be non-penicillin beta-lactam antibiotics handled to prevent cross-contamination.



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