In this section you will find all the publications prepared by APIC.
Those documents can be downloaded as a pdf file.

APIC list of  Abbreviations & Acronyms

APIC Brochure 2008

Press Release APIC Quality Agreement and Supplier Qualification and Management" Guidelines, 2010

Press Release: EFCG and APIC welcome adoption of new Falsified Medicines Directive (Feb 2011)

Industry Best Practice documents:

Good Manufacturing Practices for Active Ingredients Manufacturers, with EFPIA, 1996

Quality System for Active Ingredients Manufacturers, integrating GMP into ISO, 1997

Manufacture of Sterile Active Pharmaceutical Ingredients, guidance, 1999

The Active Pharmaceutical Ingredients Starting Material (APISM), 1999

Cleaning validation in Active Ingredient Manufacturing plants – Policy, 1999

Good manufacturing practices in Active Pharmaceutical Ingredients development, 1999

Cleaning validation in active pharmaceutical plants – guidance, 2000

"How to do" - Interprétation of ICH Q7 document & "Review Form (update May 2011)"

Computer Validation Guide, December 2002

Parametric release document, December 2002

 Technical Change Control Guideline 2004

APIC Quick Guide for API Sourcing, 2008

 The Audit Programme, Version 3, August 2010:

A) Audit Programme: Procedure

• Annex 1- Contract Auditor-ACI
• Annex 2 - Agreement Customer, Auditee, Auditors & ACI
• Annex 3 - Auditing Guide-Secrecy Agreement
• Annex 4 - Standardised Letters related to Shared 3rd Party Audits:
  - Letter 1
  - Letter 2
  - Letter 3
• Annex  5 - Feedback Form
   

B) Auditing Guide,  August 2010

• Annex 1 - Auditing Guide, Questionnaire
• Annex 2 - Auditing Guide "Aide Mémoire"
• Annex 3 - Auditing Guide,  Audit Report Template

Quality Agreement Guideline 2009
   - Appendix A: Generic APIs
           - Appendix B: Exclusive Substances

Supplier Qualification & Management Guideline, December 2009
    - Appendix 1: Examples of Critical/ non Critical Raw Materials
            - Appendix 2: Supplier Selection Check List
            - Appendix 3: Due Diligence Check List
            - Appendix 4: Supplier Questionnaires
                                    - A: General Company Information and Quality Management Questionnaire
                                    - B: BSE/BSE Risk Analysis Survey
                                    - C: GMP -  Vegetable Origin
                                    - D: Allergen
                                    - E: Extended Quality Questionnaire for Critical Material
                                    - F: Packaging Material
           - Appendix 5: Check list for Change Control Assessment

           Supplier Qualification Guideline (ZIP File)


          

 Disclaimer:
 These documents represent the views of APIC members only and do not constitute a formal regulatory guidance.