Globepharm Consulting ‚ÌGMPŠÖ˜A‹Æ–±‚Ì‚²ˆÄ“à


FDA1103-Non-Penicillin Beta-Lactam Contamination guideline (draft)@Mar. 2011


Dear Friends:

FDA has just issued (March 2011) a new draft guideline titled
"Non-Penicillin Beta-Lactam Risk Assessment - A cGMP Framework". The draft
document provides guidance on the prevention of cross-contamination in the
manufacture of:

penicillins (e.g., ampicillin, oxacillin)
cephalosporins (e.g., cephalexin, cefaclor)
penems (e.g., imipenem, meropenem)
carbacephems (e.g., loracarbef)
monobactams (e.g., aztreonam)

and specifically discusses whether these products can be manufactured in a
single facility.

This document is provided as part of Globepharm's on-going service to keep
you abreast of global regulatory thinking and changes, specifically in the
area of Good Manufacturing Practices. If we can assist in any way with GMP
gap analyses, GMP pre-regulatory inspection assessments, or with training
in any aspects of GMPs, please do not hesitate to contact me.

With Best Regards,

Michael Anisfeld
Globepharm Consulting

Deerfield IL 60015 USA


Attachment :FDA1103-Non-Penicillin Beta-Lactam Contamination guideline (draft)






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