How to perform an API Audit – Insights of the ICH Q7 Training Week 2024

   

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From 01-05 July 2024, the ICH Q7 training week took place in Vienna, Austria. This time, the event was supported by the representative of APIC's (Active Pharmaceutical Ingredients Committee) Task Force "Third Party Manufacturing" Mauro Menichelli. Many interested participants from a large variety of countries got together with the speakers to discuss and debate well-established and current hot topics in the field of APIs manufactured by chemical synthesis and APIs produced by cell culture & fermentation and their legal GMP requirements. For the complete set of speakers and attendees it was a special week: The presenter Dr Paul Stockbridge was joining the "Compliance Courses" as a speaker for the last time and shared once again his enormous GMP knowledge and Biotech experiences with the group of attendees and speakers. His contribution and support to the ICH Q7 Training Week was outstanding and we are still pleased having the chance to have him in the  speakers' team for such a long time. Now, we wish him all the best for the future and like to say again: "Enjoy your well-deserved retirement, Paul!"

After having two and a half days of the "Compliance Courses", the focus of the ICH Q7 Training Week was laid down on the topic "API Audits" and how to perform them properly and sufficient. The following days were characterized by many presentations, interactive sessions, role plays and their preparations as well as by the exchange of information and experiences between the attendees and the three presenters: Swa Vandeweyer, Mauro Menichelli and Peter C. Zimmermann. While Peter C. Zimmermann was leading the communicational and psychological aspects of the "ICH Q7 Auditor Training Course", Swa Vandeweyer and Mauro Menichelli were explaining the "APIC Audit Programme", how to become an "APIC Certified Auditor" (see also Figure 1 "APIC Audit Programme Certification Scheme" on page 29) and how to audit manufacturing sites of Active Pharmaceutical Ingredients (APIs). Core questions, on which the participants and speakers worked on together in panel discussions and breakout sessions, were the following leading ones:

1. How to prepare for specific audit situations?
2. How to write an audit report?
3. How to classify observations?

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The presenters also showed how to do the so-called audit closing meeting and tried to point out the importance of transparency during an audit and its closing. The talks of the speakers were always linked to the respective guidelines, which need to be followed, and guidance documents, which can be used for the audit preparation and during an audit. Most of these guidance documents are prepared by APIC's Task Forces like the "Third Party Manufacturing"-Task Force. As an example, Swa Vandeweyer pointed out the great benefit of the "APIC Audit Guide" and its Annex 2 the "Aide Mémoire". The "Aide Mémoire" is structured like a check list with several questions which guides you throughout all audit relevant topics and systems as well as all parts of the audited facility. These documents and a lot of further useful publications are available on APIC's website in folder "publications" and are all free of charge (https://apic.cefic.org/publications/).

As we all figured out during the pandemic that there is a need of remote audits, the relevance of this audit practice was also discussed during the "ICH Q7 Auditor Training Course" and tools to do such an audit properly were introduced and assessed - from the technical as well as the communicational point of view. After the presentations of the main facts of verbal and non-verbal communication, the analysis of questioning and conversation techniques and the development of interview techniques, the attendees had the chance to prepare their respective role plays in several groups. The role plays always contained typical audit topics and cases and showed how to manage a real audit situation - as an auditor or as an auditee. For every case, the attendees needed to use their own audit experiences and the trained communicational techniques as well as to react on every new situation. Our well experienced presenters' team helped and supported the attendees during the preparation phase as well as gave a detailed feedback - together with the participants being the audience - after the role plays were performed. The complete group was impressed of the commitment of the attendees to the real case scenarios and their outstanding performance during the role plays.

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This time in Vienna, most of the attendees of the auditor training applied for becoming an "APIC Certified Auditor". As mentioned in Figure 1 (see above) the participants needed to attend one of the "Compliance Courses" first, followed by the "ICH Q7 Auditor Training Course" afterwards. After joining all training days and performing the role plays the attendees needed to pass the so-called written exam and the internet-based test. Finally, as an outcome of these exams the attendees received the certificate of APIC mentioning them as "APIC Certified Auditors", which is a prerequisite of performing audits in accordance with the "APIC Audit Programme".  Congrats to all new auditors - well done! Once again, the ICH Q7 Training Week was full of interesting topics and beneficial for both speakers and attendees.

Figure 1: APIC Audit Programme Certification Scheme – How it works

Note: The upcoming ICH Q7 Training Week will take place live online in November 2025 and will of course offer to the registered participants the new version of the booklet "ICH Q7 Side-by-Side  Comparison", which compares the requirements of the "ICH Q7 Guideline - GMP for Active Pharmaceutical Ingredients" to the interpretations of the revised "How to do"- Document - Interpretation of ICH Q7 Guide and "Review form" (Version 17) of APIC and explains the requirements of the guideline. For more information, please visit the "ICH Q7 Training Week" website

About the Author
Anne Günster joined CONCEPT HEIDELBERG in 2019 and organises and conducts courses and conferences on behalf of the ECA Academy in the areas API Manufacturing, Regulatory Affairs, Documentation and Laboratory Data Integrity.

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