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 The
Active Pharmaceutical Ingredients Committee is a sector group of CEFIC.
CEFIC represents, directly or indirectly, about
40,000 large, medium and small chemical companies which employ about two
million people and account for more than 30% of world chemical production.
APIC has now published Position Papers on two important topics:
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CEFIC/APIC Position on
the "Procedure for the Certification of Suitability to the
Monographs of the European Pharmacopoeia" (CEP Procedure) versus
the "Drug Master File Procedure" (DMF Procedure)
You can download this Position Paper by clicking here.
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CEFIC/APIC Position on
Post-Approval Change Authorization Procedures
(PACAPs) relating to the manufacture of APIs
You can download this Position Paper by clicking here.
Every year, APIC organises the most important European Conference on
Active Pharmaceutical Ingredients. At this conference, both
GMP and regulatory affairs topics are discussed, among others with
representatives from FDA and EDQM. Please click here
in order to read the programme.
Author:
Oliver Schmidt
CONCEPT HEIDELBERG
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