ECA Group Update January to April 2022
What the ECA Foundation's Interest Groups were working on in the first four months of 2022 you can read below.
European QP Association (EQPA)
At its Board of Directors meeting in early December, the European QP Association (EQPA) had decided to concretise its requirements for membership in the Association. This was due to ambiguities in the previous requirements, changes in the political landscape and planned adjustments in PIC/S countries. The changes as available on the EQPA website apply to all new memberships. Existing membership are notm affected.
The EQPA Activity Plan 2022 was finalised and agreed by the board. Amongst other things it outlines objectives, goals and board meetings planned in 2022.
Code of Conduct for QPs
Georg Göstl took the lead to develop a draft proposal for a Code of Conduct to QPs in the name of the EQPA.
Background: Article 52 of Directive 2001/83/EC requires from member states to issue national Codes of Conducts for QPs. Alternative approaches are also possible.
According to a survey feedback, 21 years after coming into force this legal article did not result in any Code of Conduct in any current member state nor in EEA member states. All member states obviously claim to have alternative procedures developed or in place (usually without explaining to QPs which ones). The EQPA wants to fill this gap.
EQPA board members were invited to comment this first draft.
Benchmarks IMP QP Working Group
For the QP Forum 2021, participants and members of the IMP Working Group had submitted a number of questions in advance via a “Call for Questions”. Many of them have already been addressed in the presentations and in the Q&A sessions. However, due to the numerous chat questions during the conference, the speakers were not able to present all the benchmarks that were prepared based on the submitted questions. Therefore, a survey was sent out. It was also asked for possible topics of interest for the next QP Forum’s IMP Pre-Conference.
Contract QP Activities
According to Article 48 of Directive 2001/83/EC each manufacturer has to have at his disposal at least one Qualified Person. There are no details on the contractual arrangement for this “disposal of services”, though.
As QPs in many member states offer their service as independent entrepreneurs and “contract QPs”, these states have developed rules and expectations posed on independent QPs usually without own MIA. Therefore, EQPA has sent out a survey to find out more about this area of QP activities, which is not harmonized within the EU. Results will be posted in the members’ area as soon as available.
QP Forum 2022
The EQPA Board has decided to offer this year's QP Forum (01-02 December in Berlin, Germany) also as a Live Online Conference. Delegates can either attend on site in Berlin or at home/ in the office. All lectures and sessions of the main Forum will be held consecutively.
A lot of hot topics for QPs have been identified and will be discussed in the various presentations, like:
- Revised EU-GMPs
- Electronic Data
- Risk Management
- Supply Chain
Preceding the Forum, two parallel Pre-Conference Sessions on specific topics will run on 30 November: Investigational Medicinal Products and Quality Culture.
To find out more please visit the QP Forum website.
IWG meeting with Interested Parties on 10 March
EQPA and ECA were taking part at the EMA’s inspector’s Working Group Meeting with Interested Parties on 10 March (online).
The Interested Parties noted some actions during the meeting:
1. Covid-Lessons learned / GMP
2. GMP for importers (Annex 21)
EFPIA with AESGP, ECA/EQPA, EIPG, MfE, VE
3. GMP for MAH
with ECA/EQPA, EIPG, MfE, PDA
4. QP Training and operations
ECA/EQPA with EFPIA, EIPG, PDA, MfE
5. EudraGMDP update and integration of OMS
6. IMP situation Ukraine
Comments to planned revision of the ICH Q9 Guideline
In December a draft of a planned revision of the ICH Q9 Guideline was published. The ECA Foundation together with its European QP Association set up an Expert Working Group to comment on the draft. This Expert Working Group was led by Yves Samson and with the members
- Britta Abellan
- François Croizet, PQE France
- Jérôme Keldenich, Cenexi
- Philippe Lenglet, Laboratoires Servier
- Véronique Dagois, Capexpert
- Jean-Denis Mallet, Pharmaplan
- Éric Villain
To find the comments and a comparison between the documents, please see the news "ECA Expert Working Group submits Comments to ICH Q9 Draft".
The collected comments for ICH Q9 were published by EMA on 20 April.
European QP Association website
Find out more about the current courses & conferences programme organized and co-sponsered byb the European QP Association.
Pharmaceutical Microbiology Group
A board meeting was held in January, the next meeting has been scheduled for end of November.
Annex 1 on the group’s Microbiological Deviation Guide about microbial ID was written and reviewed by the board members. The comments are currently being incorporated by the authors.
Microbiological culture media are of high importance for quality assurance and control in pharmaceutical and biopharmaceutical manufacturing. Accordingly, the quality and suitability of the culture media must be ensured. Before a new batch can be used for microbiological testing, especially under pharmaceutical industry regulations, it must be properly tested for its ability to provide consistent and reliable results. Central to this is the growth promotion test (GPT). Both the USP and the EP promote this detection.
With a survey, the group wanted to collect some data on practices with regard to the Growth Promotion Test – with a special focus on the local microflora strains selection and management strategy. Answers are key for the assessment of current industry practices alignment and rationales.
Results will be coordinated with the results from the surveys of other organisations.
A first Cooperation with BioPhorum started for the Joint ECA/APIC/BioPhorum conference on Biological Raw Materials.
Pharmaceutical Microbiology Group website
Take a look at the current courses & conferences programme in pharmaceutical microbiology.
The sub-groups started to update their chapters of the Group’s Good Practice Guide “Integrated Qualification and Validation Guide”. There is a big interest in the subgroup on electronic documentation. This group wants to exchange results with ECA´s Data Integrity and IT Compliance Group. The development of a version 3.0 is planned to be published at another „Launch“ Conference in November 2022.
The Board meetings for 2022 are fixed, the business plan is updated.
Find out more about the current validation courses & conferences programme.
European GDP Association
The next annual board meeting has been scheduled for June or July 2022. Like last year, the meeting will take place online via Webex.
The group has reserved a date for the next GMP&GDP Forum 2023 in the long term to be sure that the most important stakeholders can be present on the date. Content planning is supposed to begin in the summer of 2022.
European GDP Association website
Get an overview of the current GDP events.
Visual Inspection Group
Felix Krumbein (Körber) is new member of the ECA Visual Inspection Group.
The postponed Board meeting 2021 took place online in January 2022.
The group has commented on and submitted the draft FDA Guideline on Visual Inspection in February. These comments were posted by the FDA on their regulations website. You can also sign up for updates or modifications are made on any documents within this docket (use Subscribe button).
No new updates planned until details from Annex I are published.
A survey within the group has taken place in February to identify current topics for the annual conference.
Visual Inspection Group wesbsite
Get an overview of the current events on visual inspection.
The next Board Meeting has been scheduled for October.
The group commented on the USP draft guideline on Analytical Procedures for mRNA Vaccine Quality.
An exchange with the Pharmaceutical Microbiology Group was initiated and first joint planning started.
Please also take a look at the events programme conceontrating on ATMP topics.
Data Integrity & IT Compliance Group
The group's chairman, Dr Wolfgang Schumacher, sent a draft of version 3 of the Group’s Data Integrity Guide on 22 May 2022 to the reviewer team. Feedback on “Show stoppers” is due by 12 June.
Data Intetgrity & IT Compliance Group website
Here you will get to the courses and conferences focusing on data integrity & IT compliance issues.