Separate-manufacturing-facility-for-penicillin-and-non-penicillin-products

This is in regards to below article on pharmaguideline I needed a clarification wheather we can make cephalosporin and penam in same facility with same air handling unit, equipment after proper cleaning of the area.

Reference article

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)
• monobactams (e.g., aztreonam)

As with penicillin, the section of a facility dedicated to manufacturing a sensitizing nonpenicillin beta-lactam should be isolated (i.e., completely and comprehensively separated) from
areas in the facility in which other products are manufactured. This control applies to each of the
five classes of sensitizing beta-lactams; the area in which any class of sensitizing beta-lactam is
manufactured should be separated from areas in which any other products are manufactured,
including any other class of sensitizing beta-lactam. Manufacturing that is restricted to a specific
class of beta-lactam compound (e.g., the cephalosporin family of products) generally would not
mandate separate facilities and air handling systems, and could permit production campaigning
and cleaning as sufficient control.
(Reference: USFDA Guidance for industry, Non-Penicillin Beta-Lactam Drugs:
A CGMP Framework for Preventing Cross-Contamination, April 2013)


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