2 Position Papers on APIs published by APIC

GMP News No. 241

GMP News
25 September 2002
 

2 Position Papers on APIs published by APIC

 
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:

  • 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.

  • 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
      

    Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

    OK

    Go back

    GMP Conferences by Topics

    Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

    OK