2.10.2009

Facility Design and Layout of Penicilin

3.1 Facility Design and Layout
This page will address various regulatory issues related to this section of the GMP Institute framework. Click below to view the issues that are relevant to you.

Penicillin Issues
What do the CGMPs mean by separate facilities? Must the buildings be totally separated, or are the CGMPs satisfied when the floors are physically separated with separate air filtration units installed?
Is it acceptable to manufacture penicillin and non-penicillin products in the same facility on a campaign (i.e., the conversion of production facilities to a different product line on a routine basis) basis, with adequate cleaning validation procedures in place?
Is it acceptable to manufacture penicillin products in the same facility as cephalosporin?
Can a facility that produced penicillin dosage forms be decontaminated and renovated for production of non-penicillin solid dosage forms provided there is no further penicillin production in the renovated facility?
Is there an acceptable level of penicillin residue in non-penicillin drug products?
If a firm's only operation is performing finished packaging operations for bulk tablet and capsule drug products, must it still maintain separate facilities and equipment for packaging penicillin products?
What do the CGMPs mean by separate facilities? Must the buildings be totally separated, or are the CGMPs satisfied when the floors are physically separated with separate air filtration units installed?
References: 21 CFR 211.42(d) Design, and construction features21 CFR 211.46(d) Ventilation, air filtration, air heating and cooling21 CFR 211.176 Penicillin contaminationFederal Register, 9/29/78 (Vol.43, No.190, Book 2) Preamble to the CGMPs at comment 142


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