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The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are two international instruments between countries and pharmaceutical inspection authorities. The PIC/S is meant as an instrument to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the ...
Amazon Cooperation Treaty Organization; ... Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme; R.
In countries that are part of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), the same role may be termed responsible person (RP) or authorized person (AP).
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).
There are different classifications for aseptic or sterile processing cleanrooms. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) classifies cleanrooms into four grades (A, B, C, and D) based on their cleanliness level, particularly the concentration of airborne particles and viable microorganisms.
Pharmaceutical Inspection Cooperation Scheme: GMP Guides; World Health Organization GMP Guidelines; European Union GMP Guidelines; US CFR Title 21 parts 210 (GMP, general), 211 (GMP, finished pharmaceuticals), 212 (GMP, positron emission tomography drugs), 225 (GMP, medicated feeds), 226 (GMP, type A medicated articles).
More specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested ...
Pages for logged out editors learn more. Contributions; Talk; Pharmaceutical Inspection Convention