Updates from the ECA Interest Groups
What were the ECA Foundation's Interest Groups working on in the four months between May and August 2021 - please read below.
European QP Association (EQPA)
It was decided to run this year’s QP Forum live online only (no hybrid version).
The WHO issued two revised working documents: QAS/20.863/Rev1: WHO Good Manufacturing Practices for Investigational Products and QAS/20.865/Rev1: WHO Good Practices for Research and Development Facilities of Pharmaceutical Products for public consultation. The IMP Group invited members to send in their comments and provided comprehensive comments for these documents to the WHO, which are also available in the IMP Group's download section.
Depending on individual organisations and processes established, the batch certification may happen at different points in time. With a short survey as a benchmark, the IMP Working Group wanted to gain an overview of the current practices and possible changes coming along with the upcoming Clinical Trial Regulation.
The ECA’s European QP Association is regularly approached with questions how the requirements for QP qualification as defined in directive 2001/83/EC and 2001/82/EC may be implemented differently in different Member States. EQPA has been trying to gain an overview for many years and now intends - with the help from its members - to further assess different dimensions or variations which may divert from the requirements in the directives. 231 QPs replied. Results will also be published in the members area.
On 23rd July 2021 the EMA published the Reflection paper on Good Manufacturing Practice and Marketing Authorization Holder in its final version. QPs need to have a good understanding of the contents of this new reflection paper and may need to work on identifying and closing gaps in interactions with the MAH not previously given adequate attention. These considerations provided the basis for another survey which covers the main topics of the Reflection Paper. Results are pending and will also be published in the members area.
A new issue of the EQPA Newsletter was uploaded on the download section of the members’ area with the following contributions:
- An overview of the different national solutions and approaches on article 52 and the code of conduct or equivalent and their implementation and enforcement in the various member states (based on a survey)
- Compassionate Use
- The European Medicines Agency (EMA) draft Reflection Paper on Good Manufacturing Practice and the Marketing Authorisation Holder.
Find out more about the current courses & conferences programme organized and co-sponsered byb the European QP Association.
Pharmaceutical Microbiology Group
The PharmaLab Congress will be held online this year. Therefore a Board Meeting of the Pharmaceutical Microbiology Group will be planned later this year/early next year.
The 3rd chapter of the ECA Micro Groups OOS/OOL Guideline dealing with deviations in sterility testing was published.
Take a look at the current courses & conferences programme in pharmaceutical microbiology.
Due to the corona crisis it was decided to conduct all meetings of the task force which develops the Version 2.0 of the Good Practice Guide Integrated Qualification and Validation Guide online in 2021. A full group meeting, on 15 November 2021 will be also online.
A version 2.0 of ECA´Good Practice Guide ECA´s Integrated Qualification and Validation Guide was completed, implementing feedback from the launch conference last year. The development was mainly coordinated via telecons. New subgroups cover the topics remote-FAT/SAT regulatory endorsement and contracting. The new version is supposed to be published at the Online Launch Conference on 16/17 November 2021.
Find out more about the current validation courses & conferences programme.
European GDP Association
Alfred Hunt was invited to join the Advisory Board and accepted to take over the role as a Deputy Head.
On 25 June 2021 a Board Meeting was held (Online Meeting via Webex). Current and new activities were discussed. A report with actions was finalised and circulated amongst the members. The next board meeting is planned for June 2022.
The first European GMP & GDP Forum took place from 22–24 June 2021, combining the European GMP Conference and the European GDP Forum. As travelling and face-to-face meetings are still difficult, it was decided to offer the first GMP & GDP Forum live online. Day 1 was dedicated to GMP, day 2 was a combination of both GMP, and GDP and the final day was focused on GDP topics only. Participants could choose to attend the Forum just for one of the three days, two days or all three days. The Conference worked quite well. There were a lot of interesting presentations covering a broad range of GDP topics.
In October 2020, the ECA Academy offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. During the last months, a selection of the answers has already been published. The European GDP Association answered all questions and combined them in a Q&A document. The PDF of the document is accessible free of charge in the member's area of the European GDP Association website.
The download area on the Association’s website has been revised and reorganised.
Get an overview of the current GDP events.
The Board Meeting 2021 took place in June, another meeting is planned for the end of 2021.
It was decided to check the documents of the AGORA tool box and to then decide on further actions to be taken.
In order to take account of the rapid development in the field of biological medicinal products and ATMPs, the PIC/S has revised Annex 2 of its GMP Guideline and made it available for comment.
Please also take a look at the events programme conceontrating on ATMP topics.
Data Integrity & IT Compliance Group
In a joint video conference the board members of the DI&IT Group and the Analytical QC Group planned the finalisation of the ECA DI Guide Version 3. In a first step the additions are supposed to be summarized. These additions include:
- Articles regarding current FDA DI-Warning Letters
- Updates of tables
- Deletion of Draft MHRA Guidance on DI
- Extension of PIC/s 041 by 2
- Definition of ALCOA+, a new figure
- Revision of chapter on spreadsheets
Following the “final document” will be reviewed – the publication is expected in October / November 2021.
Here you will get to the courses and conferences focusing on data integrity & IT compliance issues.