ECA Group Update September through December 2021
What he ECA Foundation's Interest Groups were working on in the last four months of 2021 you can read below.
European QP Association (EQPA)
A Board Meeting was held live online in the beginning of December. There the following topics were discussed: Feedback QP Forum 2021, Review of meeting minutes of the board meeting 2020, IMP Working Group Update and Current and Possible future projects.
The IMP Working Group had three full day virtual meetings (March/July/October) & monthly telecons. Main goal was to develop a concept and an agenda for the IMP pre-conference 2021.
After a major revision in 2020, Annex 1 of the EQPA Code of Practice for QPs was completely revised, based on a survey and feedback from members. Annex 1 summarises the EU member states’ national requirements for becoming a Qualified Person and other national specifics.
In the first half of the year, a survey concentrated on the “QP qualification requirements in different member states”. The report about the results was written by Ulrich Kissel and reviewed by David Cockburn. The survey focused on the professional route to becoming a QP and related topics. EQPA is grateful again for its members’ strong engagement resulting in a wealth of data, which was analyzed in the respective assessment. As usual in such surveys the outcome can only reflect the variety of responses received. Responses from different participants may differ only slightly or sometimes even conflict. Given the responses result from individual experiences, the authors had no desire to filter them in any way. The assessment is available in the members’ area on the website and are also be published in the EQPA membership newsletter and one of the next issues of the ECA’s GMP Journal.
Chapter 2 of the EU GMP Guide defines key personnel to be available at a pharmaceutical manufacturing company and respective responsibilities while at the same time providing some flexibility regarding the personnel taking responsibility. Depending on the organizational structure, it has to be carefully defined who takes what responsibility. With the respective survey the EQPA wanted to get an overview on how today’s organizations operate. The results, which are pending, are also supposed to contribute to a better clarification in the current GMP Guide with a better basis for influencing and commenting on potential upcoming revisions.
The QP Forum in the beginning of December was again only available as a Live Online Conference. As all lectures in the main Forum and the Pre-Conference Sessions were held consecutively, delegates could follow them at their screen.
Three parallel Pre-Conference Sessions were preceding the Forum: Investigational Medicinal Products, Human Error and Drug Device Combinations.
The online version of the Forum was very successful. Overall, 300 delegates joined over the three days. The overall rating was very positive.
The EU Commission has started a public consultation with the aim to collect views from stakeholders and the general public in order to support the evaluation of the existing general pharmaceutical legislation on medicines for human use, and the impact assessment of its revision to ensure a future-proof and crisis-resistant medicines regulatory system. Ulrich Kissel drafted the ECA/EQPA consolidated positions on how to change the pharmaceutical law in Europe. Main topics are:
- Delegated regulation instead of directive
- QP qualification requirements
- Requirements on QP experience
- Code of conduct
- Harmonized GMP Guide
- Qualified Person and safety features/serialization
The consolidated position was submitted to EMA.
The EMA has contacted stakeholders because the Agency has been informed of the potential for disruption in manufacturing of aseptically produced medicines due to significant difficulties in obtaining Single Use System components (sterile components). The Agency wants to gain a better understanding what the causes are, how widespread this issue is for manufacturers in the EU, and what mitigation measures industry is putting in place. In particular the EMA would appreciate it if stakeholders could send in further information on the impact on availability of (critical) medicines. Georg Göstl worked together with EFPIA on that, and EFPIA will respond to EMA.
EFPIA has sent a final letter to EMA/IWG on behalf of the industry stakeholders (including ECA & EQPA comments) with topics we as interested parties would like to discuss at a meeting. The Interested Parties have identified the following priority areas and propose actions/activities for consideration by EMA-IWG:
- COVID Impact: Extension of Validity of GMP certificates and new GMP certificates
- COVID impact on GMP/GDP inspection and related procedures: current practices and the way forward
- Innovation in digitalisation in manufacturing
- Reflection Paper on Good Manufacturing Practice and Marketing Authorization Holders
- EU-GMP Chapter 4/Annex 11
- Veterinary GMPs (Annex 4 & 5)
- GMP for ATMPs
The Interested Parties are also looking for specific updates on e.g.:
- GMP for sterile products (Annex 1)
- GMP for Importers – Annex 21
The Interested Parties understand that there are further topics to be addressed with the EMA-IWG including e.g.:
- Facilitation of harmonisation for implementing EU requirements in Member States
- Progress on the different MRAs
- Inspections for IMPs
Considerations on supply chain disruption of parts/components (incl. SUS) used in production
Find out more about the current courses & conferences programme organized and co-sponsered byb the European QP Association.
Pharmaceutical Microbiology Group
The next Board Meeting is scheduled for January 2022.
Based on the questions received from the last two Bioburden courses, the first chapter of a Bioburden Q&A on "Biopharmaceutical Manufacturing" was prepared. It comprises questions on the following topics:
- Bioburden Testing - Guidelines and Regulations
- Microbial Control Strategy for Biopharmaceutical Manufacturing
- Bioburden for Sterile Operations
- Assessment of Bioburden Excursions in Non-Sterile Biologics Manufacturing Processes
Authors are Dr. Sven M. Deutschmann from Roche and Sebastian Thoelken from Novartis. The publication is planned in the 1st half 2022.
A first contact with the newly set up ZEPAI was established for the purpose of evaluating future cooperation activities.
Take a look at the current courses & conferences programme in pharmaceutical microbiology.
Due to the corona crisis all meetings of the task force which developed Version 2.0 of the Good Practice Guide Integrated Qualification and Validation were online in 2021 – including the full group meeting mid of November.
The Head of the Validation Group, Gert Moelgaard, handed over the leadership to Ralf Gengenbach, gempex, at the Launch Conference conducted in November. Gert will stay with the group as a member, though.
Following the Launch Conference, minor changes (e.g. announcement of the subgroup members) were implemented in the Guide as version 2.1. Version 3.0 is planned to be published at another Launch Conference in November 2022.
In a survey about Remote FAT/SAT conducted in September/October a total of 140 provided feedback. Results were summarized in the news Results Survey Remote Factory Acceptance Tests (Remote FATs).
Find out more about the current validation courses & conferences programme.
European GDP Association
Emil Schwan moved from the Board to the Authority Advisory Board, of which he was already a member from 2017 until May 2020.
Emil Schwan is a pharmacist with experience from performing GMP and GDP inspections, formulation development, manufacturing of medicinal products and pharmaceutical quality systems. Emil has been chief designer for medicinal products of several dosage forms. Emil comes from the Swedish Medical Products Agency (MPA), where he spent eight years as a pharmaceutical inspector. As an inspector he inspected sites in Sweden and in countries outside the EU, e.g. China, India, USA. He has knowledge in GMP and GDP for both medicinal products and active pharmaceutical substances. After working as a Senior Consultant for RegSmart Life Science AB, he returned as an inspector with the MPA in November 2021.
The Medicines & Healthcare products Regulatory Agency (MHRA) held a webinar "Protecting the medicines supply chain from falsified medicines". Several members of the board attended the event for information purposes.
Get an overview of the current GDP events.
Visual Inspection Group
Felix Krumbein from Roche Diagnostics is a new member of the ECA Visual Inspection Group Board.
The Board meeting planned for November 2021 has been postponed and will take place in January 2022.
Get an overview of the current events on visual inspection.
The Board Meeting took place end of November, where a new Business Plan was created.
The board members received a Survey from the EMA to stakeholders to identify the top priorities of the future Quality Innovation Group (QIG) with a request for feedback.
Please also take a look at the events programme conceontrating on ATMP topics.
Data Integrity & IT Compliance Group
The publication of the DI Guide is delayed. It is planned to be published as version 3 in Q1 2022. Afterwards, the Board will decide whether a version 4 with a new structure should be tackled.
Here you will get to the courses and conferences focusing on data integrity & IT compliance issues.