. ICH Q7 WEEK .

Best Practice Guides

Publications

In this section, you will find publications prepared by APIC related to the APIC Auditing Programme. Those documents can be downloaded as a pdf file.

"How to do" - Interpretation of ICH Q7 document & "Review Form", version 15, July 2021
After the Live Online Training, all participants will receive by mail APIC‘s Side-by-Side Comparison of “ICH Q7 GMP for Active Pharmaceutical Ingredients” and the “How to do Document” - APIC’s Interpretation of ICH Q7.

Auditing Guide, 2016

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

Audit Programme, Version 6, November 2020

All documents can be found here: http://apic.cefic.org/publications.html