GMP for APIs - Live Online ICH Q7 Training Week - Interviews
At the end of 2021, the ICH Q7 Training Week was held as a live online event and was once again supported by the representative of the APIC Task Force "Third Party Manufacturing" Dr Jens Brillault. For the first time, together with Francois Vandeweyer, who is one of the well-known speakers of the ICH Q7 Training week, he has committed to answer in an interview the most important questions and topics in relation to the Compliance and Auditor courses of the Training Week.
Both Compliance Courses "ICH Q7 Compliance for APIs Manufactured by Chemical Synthesis" and "ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation" had lectures to compliance topics from the areas of chemical and biotechnological manufacturing of active pharmaceutical ingredients (APIs) and informed about the topics GMP and legal requirements of active pharmaceutical ingredients. That is why the first questions, which was raised in the interview, was named "What, in your opinion, are the most crucial points when it comes to the implementation of ICH Q7?". Dr Jens Brillault and Francois Vandeweyer gave the following answers:
Brillault:
a) Initial establishing of a Quality management system (QMS) according to ICH Q7: Guidelines only tell you what to do, not how to do. How to do documents or Q&A documents issued by authorities could help a lot. I assume that one can't establish such a system without support of experienced employees (e.g. consultants).
b) Lifecycle of QMS: Every system has to be dynamic. Otherwise it will be outdated soon. So it is important to improve and adopt the QMS frequently to updated regulations or industry best practice. Checking latest APIC documents or exchange with other companies could help (e.g. in APIC Task forces). Also training/ seminars are suitable to stay informed about changes and updates.
Vandeweyer:
The right quality culture, supported by management, must be in place. ICH Q7 requirements implementation will only be successful, if all departments and all employees support the quality mind set.
 Francois Vandeweyer... worked for Johnson & Johnson in various positions for many years and now operates as a freelance GMP consultant. |
In relation to the first question and the implementation of ICH Q7 we asked "What are the most common problems and mistakes when implementing ICH Q7?". The speakers answered as follows:
Vandeweyer:
ICH Q7 should be read as a whole. Meaning, if you read chapter by chapter on its own and start implementation problems and mistakes will occur. Important is to see and understand the relationship between the chapters. Example: When implementing the requirements of the chapter on "documentation". This must be reflected in all other chapters like Roles & Responsibilities, validation, Facitlities, lab,…..
Recommendation
5/6 February 2025
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Brillault:
The implementation of a GMP QMS cannot only be manged by the Quality Unit. Understanding and acceptance of GMP aspects/ rules must be broadly distributed over the whole API site. The principle of "Quality Culture" must be applied. This means every department needs to understand its role in the overall manufacturing process and everybody must understand and accept his contributing role to build a mature and well operating QMS and finally to ensure patients safety.
As Francois Vandeweyer, who was formerly the representative of the APIC Task Force "Third Party Manufacturing", is a speaker of the ICH Q7 Training week for a long time, we additionally asked him to answer the question "You have been part of the ICH Q7 Week for several years now. How does the course, and its set-up, benefit the participants?".
Vandeweyer:
The combination of information on hot ICH topics by experienced speakers and soft skills auditor training is a unique concept. Related to the ICH topics the information presented during the courses is focussed on "How to do it", "How to implement the ICH Q7" and "What to do"- rules. Related to the auditor training the focus is here in soft auditing skills. How to deal with difficult audit situations (talkative auditee - silent auditee - angry auditee,…) trained in active role plays. It will become clear that a good auditor must be a good listener and a good observer.
Also this ICH Q7 Training Week, which was held on 22-26 November 2021, was yet again characterized by the questions and comments of the participants, to which the speakers were always happy to respond and suggest solutions. Additionally, to support the implementation of the ICH Q7 requirements, all participants also received the new edition of the "ICH Q7 Side-by-Side Comparison" booklet, which compares the "ICH Q7 Guideline - GMP for Active Pharmaceutical Ingredients" requirements with the "How to do"- Document - Interpretation of ICH Q7 Guide and "Review form" of APIC, by mail - even though we were not able to meet in person in 2021, we do not want to give up this long-held tradition and will continue it.
 Dr. Jens Brillault... is Quality Director at CU Chemie Uetikon in Germany and actively involved in the work of the APIC task forces. |
As usual, the Compliance Courses were followed by the ICH Q7 Auditor Training Course of the APIC Audit Program. Last year, the course was characterized by the great participation and interactivity of the participants and speakers. During the two days of the auditor course, not only surveys, presentations and Q&A sessions, but also the execution, presentation and subsequent analysis of role plays took a central position and shed light on the new daily audit routine created by the corona pandemic - remotely and onsite.
Dr Jens Brillault opened the course as APIC representative and gave a detailed overview of the APIC Audit Program and the activities of the APIC working groups. The requirements and prerequisites that APIC places on auditors were clearly listed and explained. Francois Vandeweyer then presented specific audit situations and showed how to prepare for them. Using surveys, he guided participants through each scenario and helped them develop solutions to specific issues.
Due to the special situation created by the corona pandemic in 2020/2021 and the resulting changes in the pharmaceutical industry, the topic of remote audits was of great importance throughout the entire auditor training course and was examined again in detail in the presentations. That's why we've asked the speakers to respond on the following question "What are the most important things to keep in mind when conducting remote audits?".
Brillault:
Schedule a preparation meeting and check IT systems and communicate documents, which should be available during the audit. A splitting of the audit time on more than one day could be useful (e.g. 2 days (each day 5 hours), instead of one day with 8 hours). This will allow the auditee to prepare requested documents (very relevant if there is paper based system in place).
Vandeweyer:
Prepare, Prepare, Prepare!!! Preferably: 1-2 months before the audit - Auditor and the site Quality Head should discuss the audit and related documents (questionnaire, pre-audit documentation, virtual tour of GMP areas, time-zone differences, use of translators if applicable). 2-4 weeks before audit: Additional documents/records if required and test communication tools for virtual inspection rooms including back-up.
This feedback directly brought us to the next question named "In your experience, what are the most common problems and mistakes with remote audits?", which was answered as follows:
Vandeweyer:
- Time is the biggest enemy of an auditor, even more for remote audits than for on site audits.
- Take into account culture differences when having face time meetings and potential time differences.
- Make sure you consider:
- the Lack of face-to-face interaction and inability to observe body language.
- Auditors are unable to observe facility and equipment cleanliness and maintenance plus operating processes without virtual tours.
- Small sites can only support one audit stream
- Technology and connectivity dependent, test upfront
Brillault:
- IT issues are not checked/ solved upfront.
- Unstable Internet connections.
- Details regarding site tour not clarified upfront (pictures, video or live streaming?).
The final question was also related to remote audits. As this topic is of high interest and still needs to be set up by many companies we were interested to know "What advice would you give a company that is only just starting to conduct their audits remotely?". Dr Jens Brillault and Francois Vandeweyer provided the following feedback:
Brillault:
Start with a risk assessment for selection of sites/companies where a remote audit makes sense at all. Start with a low priority supplier, so that you can gain experience and improve your process/audit style before you carry one with critical audits.
Recommendation
Thursday, 13 February 2025 10.30 - 15.45 h
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Vandeweyer:
Avoid working with pre-recorded movies or pictures from the facility. Better is to be prepared to be able to support virtual tours. Test supportive systems and make sure a strong confidentiality agreement is in place before sharing documents. Take into consideration that screen shots can be made. The best is, if possible, to share documents on a secure "server" - "cloud" designed for this audit with strong access control.
The final Q&A session was followed by the final written exam for some of the participants seeking for the APIC Audit Program certification, which traditionally marks the end of the ICH Q7 Training Week.
Note: The ICH Q7 Training Week will again take place from November 21 - 25, 2022 in Heidelberg, Germany. This year's ICH Q7 Week auditor course will again feature new aspects of remote and onsite auditing - on the one hand through the speakers' presentations and case studies, and on the other hand through the audit situations presented by the participants. Further information can be found on the "ICH Q7 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.
