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

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

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 Q7A document & "Review Form", February 2010

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, January 2008

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

Auditing Guide, September 2008

• Appendix A - Auditing Guide Secrecy Agreement
• Appendix B - Auditing Guide Questionnaire
• Appendix C - Auditing Guide Aide Mémoire
• Appendix D - 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.