2 Position Papers on APIs published by APIC

GMP News No. 241

25 September 2002

2Position Papers on APIs published by APIC

TheActive Pharmaceutical Ingredients Committee is a sector group of CEFIC.CEFIC represents, directly or indirectly, about40,000 large, medium and small chemical companies which employ about twomillion people and account for more than 30% of world chemical production.

APIC has now published Position Papers on two important topics:

  • CEFIC/APIC Position onthe "Procedure for the Certification of Suitability to theMonographs of the European Pharmacopoeia" (CEP Procedure) versusthe "Drug Master File Procedure" (DMF Procedure)

  • CEFIC/APIC Position onPost-Approval Change Authorization Procedures(PACAPs) relating to the manufacture of APIs


Oliver Schmidt


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