Publications

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

Industry Best Practice documents:

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

Quality System for Active Ingredients Manufacturers, integrating GMP into ISO, 1998

Manufacture of Sterile Active Pharmaceutical Ingredients, guiance, 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" - Interpretation of ICH Q7a document & "Review Form"

Computer Validation Programme, August 2002

• Appendix A - Auditing Guide Secrecy Agreement
• Appendix B - Auditing Guide Questionnaire
• Appendix C - Auditing Guide Aide Mémoire
• Appendix D - Auditing Guide Audit Report Template

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

Qualification of existing equipment 2004

 Technical Change Control Guideline 2004

Quality Management System (QMS) for APIs 2005

 Disclaimer:

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