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 Training Courses, all participants will receive 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: https://apic.cefic.org/publication/apic-auditing-guide/