E-drug: GMP requirements
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South African greetings to all!
Assistance would be appreciated with regard to the GMP standards for
the manufacturing of Penicillin and Cephalosporin containing products:
What is the usual requirement for the secondary packaging of
penicillin products (eg. products already blistered / injectables being
packed into the outer container?). Would a separate dedicated area
with the necessary air pressure differentiation be a requirement?
Could the manufacturing of cephalosporins and penicillin be allowed in
the same area provided that validated cleaning procedures exist
between the manufacturing of the different types of products? Would
the manufacturing of these products be allowed in the same plant as
other pharmaceuticals provided that a dedicated area with the required
negative air pressure is available or is the requirement a separate
building all together?
Regards,
Joey Gouws
Inspectorate, Medicines Control Council
Department of Health, South Africa
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