Report on the 2026 ICH Q7 Training Week in Berlin: GMP Compliance meets Audit Expertise
Programme and Key Content of the Training Week
The 2026 ICH Q7 Training Week took place in Berlin from 29 June to 3 July. It combined two parallel compliance courses with the subsequent ICH Q7 Auditor Training Course. In the compliance courses, participants could choose between a focus on “APIs from Chemical Synthesis” and a focus on “APIs from Cell Culture/Fermentation”.
The first day began with a joint programme covering APIC, the APIC “How to do Document”, the ICH Q7 Q&A document, quality agreements, the supply chain, distribution, risk assessment and validation. The ICH and its relevant quality guidelines were also introduced. From a GMP inspection perspective, typical topics and common observations relating to API manufacturers, as well as preparation for inspections, were explained.
On the second day, the two compliance courses continued separately. The course "APIs from Chemical Synthesis" focused in particular on cleaning validation, equipment qualification and calibration, engineering, material and personnel flows, water quality and containment. The biotechnology course covered cell banks, culture media, fermentation, viral impurities, and the qualification and documentation of master and working cell banks. Interactive exercises enabled the participants to deepen their understanding of process and cleaning validation, the auditing of API starting materials and risk-based assessment.
On the third day, both courses focused on life-cycle management and continual improvement of processes. Topics included supplier qualification, reduced testing, data integrity, change management, stability testing and the implementation of ICH Q3D.
In the afternoon, the Auditor Training Course began with the fundamentals of good auditing practice, the APIC Third Party Audit Programme, and the preparation, conduct and documentation of audits. The following day focused on communication and psychology in auditing. Topics included active listening, questioning and interviewing techniques, non-verbal communication, cultural aspects and dealing with conflicts. In role plays, the participants worked through realistic audit situations and subsequently received detailed feedback.
The training week concluded with the closing meeting, audit summaries, the evaluation of findings, follow-up audits and remote audits. Candidates for the APIC Auditor Certification also completed a written examination and a final internet-based test on current GMP topics. Successful completion of this auditor course is the basis for recognition as a certified auditor under the APIC Audit Programme.
The APIC Third Party Audit Programme
The “APIC Audit Programme” is an external audit programme for assessing API manufacturers, distributors, contract manufacturers and/or contract laboratories. Its objective is to provide a consistent, risk-oriented and transparent assessment of the implementation of ICH Q7.
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Handling Changes and Variations
The APIC Audit Programme enables pharmaceutical companies to assess API manufacturers systematically and independently for GMP compliance. An audit may be commissioned by one or more marketing authorisation holders from the API Compliance Institute. The API manufacturer itself may also initiate an assessment, for example to prepare for a regulatory inspection or to evaluate its own compliance with ICH Q7.
Three audit options are available:
• Audit by a single customer:
A customer has the API supplier assessed by one auditor in a two-day audit.
• Joint audit by several customers:
Several pharmaceutical manufacturers participate in a two day audit conducted by two auditors. The resulting costs are shared among the participating customers.
• Mock inspection or mock audit:
An API manufacturer commissions a two-day audit by one auditor to assess its own level of compliance with the requirements of ICH Q7.
Commissioning an APIC Audit
Preliminary Discussions
Before an interested customer places an order, the API Compliance Institute holds preliminary discussions on the following topics: the scope of the audit, the steps in the audit process, the estimated time required and the anticipated costs, etc. Once the customer has signed a contract with the API Compliance Institute, the commission is deemed to have been placed and the next steps can be initiated.
Audit Preparation
To obtain initial information about the company (the auditee) and plan the audit effectively, the company is sent a questionnaire in advance. Once the completed questionnaire has been returned to the API Compliance Institute, the auditors are selected on the basis of the information it contains. The questionnaire is provided to the selected auditors for their preparation. The company (the auditee) appoints a contact person (the audit coordinator) who is responsible for conducting the audit.
Selection of an APIC-Certified Auditor
The APIC Compliance Institute generally selects one or two certified auditors from its register. The company (the auditee) is informed of the auditors’ names. The company has the right to reject the appointed auditors, but must provide reasons for doing so. In this case, new auditors are selected.
Audit Preparation and Conduct
Before the audit, the auditors provide the company (the auditee) with an audit plan covering the key topics and a provisional timetable. Immediately after the audit, all important findings and outstanding questions are discussed and clarified during the closing meeting.
Finalisation of the Audit Report
No later than three weeks after the audit, the audited company receives a draft audit report. This contains an executive summary and a detailed list of findings. The audited company may respond to the findings and propose corrective actions, responsibilities and time frames. The final audit report is approved by the API Compliance Institute before being sent to the audited company. The audited company receives the original report for unrestricted use.
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The basic audit report is generally valid for three years. To extend its validity, a repeat audit may be commissioned before this period expires. As the APIC Audit Programme is international in scope, both the audits and the audit reports are conducted or prepared in English.
Selection of APIC-Certified Auditors
Auditors conducting an audit on behalf of the APIC Audit Programme must meet the following requirements:
- Participation in an ICH Q7 compliance course followed by special APIC auditor training and successful completion of the examinations
- At least five years’ experience in GMP-compliant pharmaceutical or API manufacturing
- At least ten external audits during the past three years (at least one audit per year must concern APIs, intermediates or starting materials for which ICH Q7 is the standard)
- Participation in recognised training courses or conferences on current GMP topics
- Conclusion of a contract with the API Compliance Institute defining the auditor’s duties under the APIC Audit Programme
The API Compliance Institute maintains a list of certified auditors. Certification is valid for three years. Re-certification of the auditors is carried out as required.
About the Author
Dr Christian Arndt is Operations Director at CONCEPT HEIDELBERG and organises and conducts courses and conferences for the ECA Academy in the areas of Regulatory Affairs, Documentation and Laboratory Data Integrity.
