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Cephalosporins and Penems

Dear Forum
I read on HUMAN DRUG CGMP NOTES (Volume 8, Number 1) March, 2000 (page 6) the
following sentence:
***... Therefore, although not a specific requirement of sections 211.42 (d),
211.46(d) and 211.176, it is recommended that manufacturing operations for
cephalosporins, penems and cephems, be separated from non-beta-lactam products
and other beta-lactam drug products.*
I would like to ask you if the above sentence means that it is possible, afer
cleaning validation study,  to manufacture cephalosporins and penems using the
same equipment (e.g. reaction vessels, dryers) .
Thanking you in advance for your help, best regards
Stefano Salmieri
USA Regulatory Affairs manager
salmieri@login.it

Stefano





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