ECA Group Update January through April 2023

Following you can read what the ECA Foundation Interest Groups' were working on and accomplished in the first four months of 2023.

Pharmaceutical Microbiology Group

Board Developments
The next meeting of the Board will be conducted on 20 November 2023.

Marcel Goverde decided to leave the board. His successor on the board will be Dr Andre Kriegeskorte, Global SME Microbiology & Microbiology Innovation Hub Lead, Global Quality Control & Product Quality (GQCPQ). Who will be the new Vice Chair is still to be decided.

Dr Sven Deutschmann participated in the EDQM/EPAA-Meeting on Pyrogenicity in Brussels.

Pharmaceutical Microbiology Group website

Take a look at the current courses & conferences programme in pharmaceutical microbiology.

Analytical Quality Control Group

Board Developments
Dr Joachim Ermer joined the Advisory Board.

An online Board meeting took place on end of March 2023, and the next online meeting is scheduled for mid of June 2023.

Guideline Developments   
During the Board meeting in March, a schedule for review and updating of existing guidelines was agreed on. The preparation of new guidelines was also addressed. Further details will be discussed at the upcoming board meeting.

Analytical Quality Control Group website

Take a look at the current courses & conferences programme in analytical quality control.

Validation Group

Board Developments  
The Board is still unchanged. Next meeting is planned on-site on 28 June 2023.   

Guideline Developments   
The version 2.2 of ECA´Good Practice Guide ECA´s Integrated Qualification and Validation Guide is currently under revision. A new draft of the chapter categorisation and an annex about this topic is currently in discussion within the editing group. A template for simplified versions of the chapter is drafted. The new CARA section is ready. For 2023 further plans are

  • Finalisation of the chapters “Categorization” and “CARA”
  • Collection of more practical examples to bring into the appendices (more content). Can later be transferred into small Pixi Booklets and videos
  • Addition of a small section about most important GEP activities / process flows being a prerequisite for successful qualification
  • Simplification of the guide for easier understanding   

For all courses and conferences coming up, please see the current validation courses & conferences programme

Validation Group website

European GDP Association

Board Developments
The next Board meeting is scheduled in June 2023 (via Webex).

The GMP & GDP Forum will take place in June 2023 in Barcelona. Some members of the Board are part of the speaker’s team. For more information on the programme, please see the GMP & GDP Forum website.

European GDP Association website

Get an overview of the current GDP events.

Visual Inspection Group

Board Developments
The next Board meeting is planned for end of September 2023 in Vienna prior to the conference on 26/27 September.

Felix Krumbein develops a survey which will be used in the context of the next Visual Inspection Conference in order get some information of the audience:

Artificial intelligence in visual control will be given greater attention.

Visual Inspection Group website

To find out what courses/conferences are coming up, please see the current events overview.

ATMP Group

Board Developments  
Dr. Andrea Hauser and Hiltrud Horn decided to leave the board. There has not been a decision about the successors yet - and with that the position of the vice chair is currently vacant. Proposed new members are Katja Aschermann, Tetec, and Kati Kebbel, Fraunhofer Institute. The next meeting is planned online for beginning of June 2023. The next live meeting will be scheduled at the next ATMP Conference.

ATMP Group website

Please also take a look at the events programme concentrating on ATMP topics.

Data Integrity & IT Compliance Group

Guideline Developments
Version 3 of the DI Guide was issued and is available in the members’ area of the Data Integrity & IT Compliance Group website.

The group sumbitted comments on the Concept Paper on EU GMP Guide Annex 11. For more information please see the respective news.

The group plans to develop a new seminar on AI in October 2023 and to be part of the Pharma Congress 2024 with AI / Digitalisation.

Data Integrity & IT Compliance Group website

Here you will get to the courses and conferences focusing on data integrity & IT compliance issues.

European QP Association (EQPA)

New Task Force on “Clinical Trial Regulation implementation experience”
The IMP QP Working Group board plans on setting up a Task Force dedicated to the “Clinical Trial Regulation implementation experience” and has send out a mailing to the members to ask for support.

Guideline Developments
The European QP Association had updated its Code of Practice for QPs (Duties and Responsibilities for Qualified Persons in the EU) – Version 9.0 which was available for free for a short period in the open part of the EQPA website. A new Code of Conduct was added as chapter 3 entitled “Ethics for the Qualified Person – A Professional Code of Conduct”. The new code is specifically intended to define and ensure the ethical dimension for QPs. It might also be used in informing other groups (e.g., senior management) of the specific duties of the QPs. It is further intended to become a reference to QPs and NCAs.

Three months later, the Code was updated again (Version 10.0). Besides general linguistic changes and a structural review for clarity, the following amendments were made:

  • new elaborated chapter on Brexit and consequences
  • revision of chapter on clinical trials, adoption to Clinical trial Regulation
  • update on all references to the Clinical Trial Regulation, Veterinary Medicines Regulation and ATMP Regulation/GMP Part IV
  • integration of Annex 21 for importation
  • integration of EQPA survey results as appropriate

Thew new version 10.0 is available for members in the members' area of the European QP Association website.

QP Forum 2023
The EQPA Board has decided to offer this year's QP Forum (12-13 October, Vienna, Austria) also as a Live Online Conference. Delegates can either attend on site in Vienna or at home/ in the office. All lectures and sessions will be held consecutively.

A lot of hot topics for QPs have been identified and will be discussed in the various presentations, like, for example:

Digitalisation (AI, Blockchain)
Import/ Export
Personalised Medicine
Parametric Release
Contamination Control Strategy
and many more.

Preceding the Forum, three parallel Pre-Conference Sessions on specific topics will run on 11 October: Investigational Medicinal Products, Quality Culture and one for new QPs. For more information, please see the QP Forum website.

The December issue of the EQPA Newsletter was issued and is available in the download section of the members’ area. In that new issue you will find articles on

  • The development on GMP classification of fiscal imports
  • A summary of the survey results on extended QP responsibilities based on national legislation
  • The ideal managed access / compassionate use legislation and on
  • Quality management reviews.

EMA Meeting with Interested Parties
During the meeting of the GMDP Inspectors Working Group (IWG) meeting with Interested Parties, on 08 March 2023, future GMP were discussed like for example remote certification, Annex 11, GMP for MAHs and decentralised manufacturing.

European QP Association website

Find out more about the current courses & conferences programme organized and co-sponsered by the European QP Association.

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