ICH Q7 Training Week 2022
For the first time, the ICH Q7 Training Week took place as a Live Online Training at the end of 2020!
Finally, in November 2022, the training week was back on-site. For this, from November 21-25, 2022, many interested participants from a large variety of countries met in Heidelberg together with the speakers to discuss and debate well-established and current topics in the field of chemical and biotech APIs and their legal GMP requirements. This time, the event was supported by the representative of the APIC Task Force "Third Party Manufacturing" Danny De Scheemaecker.
Participants of the compliance courses selected one of two main topics in advance: "ICH Q7 Compliance for APIs Manufactured by Chemical Synthesis" or "ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation". On Day 1 and Day 3 of the training week, the participants listened to the joint programme of the compliance courses.
On the second day of the training week, the group of attendees was divided into two groups for the parallel sessions. During the presentations and workshops of the parallel sessions, the attendees and speakers had the chance to engross and examine the respective topics in detail.
The Auditor Training Course of the APIC Audit Programme of the ICH Q7 Training Week started on the third day at noon - this year extraordinarily supported by two APIC representatives. In addition to Danny De Scheemaecker, Mauro Menichelli as another representative of the APIC Task Force "Third Party Manufacturing" was always willing to provide advice and support. Additionally to the presentations and Q&A sessions, the execution, presentation and subsequent analysis of the role plays took a central position during the Auditor Training Course (see also Figure 2 further down).
Monday, Joint Programme, Part 1:
Danny De Scheemaecker, representing APIC, a sector group of the European Chemical Industry Council (CEFIC), opened the first day of the course by presenting APIC's activities and its publications, such as the new edition of the "How to do" document - Interpretation of ICH Q7 Guide and "Review form" for APIs. Subsequently, the compliance course day was characterized by the presentation and explanation of ICH and its Quality (Q) guidelines by Francois Vandeweyer and the responsibilities and tasks of the Q units of the manufacturing pharmaceutical companies by Dr Paul Stockbridge. Furthermore, the topic of GMP inspections was examined from a wide variety of viewpoints by the speakers Dr Frank Sielaff, Francois Vandeweyer and Dr Paul Stockbridge. In addition to presenting the most common deficiencies that can occur during GMP inspections at API manufacturing facilities and the most important points regarding inspection preparation, Dr Frank Sielaff showed the view of the regulatory authority with regard to API inspections and their requirements. Another key point was the presentation of the ICH Q7 Guideline "Questions and Answers" document, which is intended to be a further aid to understanding the ICH Q7 requirements and which Francois Vandeweyer skilfully put into context with the APIC publication "How to do" - Document - Interpretation of ICH Q7 Guide and "Review form" for APIs in an interactive session. The first day of the course was concluded with a visit to Schwetzingen Castle followed by dinner.
Fig.1: ICH Q7 Training Week in Heidelberg, November 2022.
Tuesday, 27 February 2024 10.30 - 16.00 h
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Tuesday, Parallel Sessions, Part 2:
On the second day of the compliance courses, the audience was divided into two groups - one part listened to presentations on the topic of chemically produced APIs and the second part gained insights into the biotechnological production of APIs. In addition, participants were able to choose from three workshops, where they could explore the topics in greater depth in small groups.
The presentations and workshops held in the topic regarding chemically produced APIs included the topics of purification validation, defining API Starting Materials, implementation of ICH Q11 specifications, equipment qualification and calibration as well as their design and process validation and were presented by Peter Mungenast, Ralf Gengenbach, Francois Vandeweyer, Danny De Scheemaecker and Dr Paul Stockbridge.
Dr Andy Bailey, Paul Lopolito and Dr Paul Stockbridge were the speakers of the biotech course and explained in their lectures and workshops the method of GMP inspections for biotech manufacturing companies as well as procedures for process validation, cleaning of the equipment used and its cleaning validation. They also showed the risks of virus contamination, highlighted the topic of risk assessment and provided insights into the topic of cell banks and their testing and qualification.
Fig. 2: Overview of the ICH Q7 Training Week
28/29 February 2024
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Wednesday morning, Joint Programme, Part 3:
The third day of the compliance courses was dedicated to the topics of "Life cycle management and continuous improvement" of APIs.
Dr Paul Stockbridge and Francois Vandeweyer, together with Dr Markus Dathe, held the third day of the training and outlined the steps required by the ICH Q7 guideline for supplier qualification and made suggestions for strategies to reduce the volume of testing. Additionally, the topics of Change Control Management, Data Integrity and the implementations of the ICH Q3D requirements were discussed in depth and the topic of stability studies and their testing was highlighted. Francois Vandeweyer gave detailed advice and suggestions for action in this regard and responded in detail to the questions and comments of the participants.
Wednesday afternoon, ICH Q7 Auditor Training Course:
As usual, the ICH Q7 Training Week auditor course followed up on the compliance courses.
Danny De Scheemaecker again opened the course as APIC representative and gave a detailed insight into the APIC Audit Programme as well as the activities of the APIC working groups. The requirements and prerequisites that APIC expects by auditors were clearly listed and explained.
Francois Vandeweyer then presented specific audit situations and showed how to prepare for them. Using interactive sessions, he guided participants through the individual scenarios and helped them to develop solutions to specific issues. Likewise, he highlighted common audit observations and explained which criteria should be included in an audit report. To conclude the first day of the auditor training course, the participants and speakers went on a guided tour of Heidelberg's old town together, followed by a meal in a brewery.
Thursday, ICH Q7 Auditor Training Course:
From this point on, Peter C. Zimmermann further enriched the course with a presentation of communication styles and types and showed cultural differences in this regard. In addition to individual lectures, role plays were prepared, performed and analyzed by the participants and speakers in order to recognize and internalize important communication characteristics. The fourth day of the course concluded with the preparation of the role plays on the following day of the course and left all participants and speakers looking forward to the last day of the seminar with joyful anticipation.
Friday, ICH Q7 Auditor Training Course:
The last day of the ICH Q7 Training Week started with two more role plays and their analyses, both of which were supposed to reproduce a classic audit situation, and were always supported by the speakers' tips and comments, giving the participants the opportunity to test their skills both as an auditor and as an auditee. Francois Vandeweyer and Peter C. Zimmermann also highlighted the opportunities and innovations offered by remote audits in their presentations. This was followed by the last lecture of the ICH Q7 Training Week on how to do the wrap up meeting of an audit and present the deficiencies in a factual manner. This was underlined and explained with the help of examples. After the final discussion round, the written exam followed for some of the participants who were aiming for the APIC Audit Programme certification, which traditionally marks the end of the ICH Q7 Training Week.
As usual, the ICH Q7 training week was characterized by the questions and comments of the participants, to which the speakers were always happy to respond and suggest solutions. After the course week, all participants received certificates of participation and the new edition of the "ICH Q7 Side-by-Side Comparison" booklet.
Note: The ICH Q7 Training Week will again be held as a live online event from November 20 - 24, 2023. Furthermore, the next ICH Q7 Training Week event on-site will take place from 01-05 July, 2024 in Vienna, Austria – so you can choose how you would like to participate. For more information, please visit the "ICH Q7 Week" website!
About the Author
... 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.