Updates from the ECA Interest Groups
What were the ECA Foundation's Interest Groups working on in the first four months of 2021 - you will find out below.
European QP Association (EQPA)
As discussed in the Board Meeting, the two online discussion forums on the EQPA website (IMP and the regular one) were combined. The IMP discussion forum will remain as a “read only” forum for the time being, allowing members to still have a look at older entries. A link was added leading directly to the regular discussion forum.
The IMP Working Group has commented WHO’s Working Documents QAS/20.863 “Good manufacturing practices for investigational products” and QAS/20.865 “Good Practices for Research and Development Facilities”. Documents were submitted to WHO and posted in the IMP Group's download section on the website.
The Group has also published a regulatory requirement summary on Compassionate Use/ Managed Access for QPs. The Summary contains the requirements on 40 different Compassionate Use/ Managed Access types from 28 countries of the EU/ EEA and the UK and can be downloaded in the members’ area. A summary article of the results was also prepared for publication in the June edition of the EQPA Newsletter.
Job Description: Under the leadership of Georg Göstl, the EQPA developed and published a Job Description Template for QPs.
After one year under the measures to cope with the COVID-19 pandemic the EQPA asked for an update on the overview of different national requirements/expectations from the QP regarding presence on site and remote certification. A survey on this was already sent out about one year ago. But a lot has happened since the early days of the pandemic and procedures and approaches have been adjusted officially by Health Authority communications as well as internally in your organizations and work places. With this survey the EQPA wanted to learn more about changes to these expectations in the view of inspectors as well as the members’ view and perception. A summary of the results were published in the members’ survey section on the website.
Another survey was conducted on Directive 2001/83/EC articles 48 till 52: this Directive forms and defines the legal framework of the role of the QP in the five articles 48 till 52. Discussions often focus on article 49 defining the minimum requirements to become a QP. Less attention is often given to the provisions set by article 52. The EQPA wanted to get an overview of the different national solutions and approaches for article 52 compliance, QPs’ experiences and assessment. The survey therefore specifically focused on the way and mechanisms how article 52 and the code of conduct or equivalent are being implemented and enforced in your member state. The results were prepared for publication in the June edition of the EQPA Newsletter.
The EQPA was further invited by EMA’s GMDP IWG for a teleconference with other stakeholders end of January. For preparation of the meeting, EFPIA invited for a coordination call to discuss. The main topics discussed were:
- The EMA GMP/GDP -IWG Working plan 2021; covering progress on new/updated guidelines such as;
- Inspection and Audit Management in a changing environment.
- Update on the actions agreed at the PRIME/Breakthrough workshop.
- EFPIA’s meeting minutes were provided by Ulrich Kissel to the Board.
David Cockburn and Ulrich Kissel worked on an article on Remote Certification which will be published in Euromed’s magazine Industrial Pharmac.
David Cockburn has further written an article for Euromed Publications GMP Review: Good Manufacturing Practice and the Marketing Authorisation Holder (When does a marketing authorisation holder have to comply with GMP?) The article was also prepared to be published in the June edition of the EQPA Membership Letter.
The EQPA was contacted by the French National Chamber of Pharmacists, which is interested in getting into contact and liaison with EQPA. A video call was set up with the Director of the chamber of Pharmacists in France and Deputy Vice Chairman of responsible persons in France to share intents and thoughts. They are highly interested to engage and willing to advertise their members to sign in as members and engage for EQPA. Further discussed were also the code of conduct for QPs, other opportunities of EU alignment, the role of the Pharmacien Responsable, remote certification and other topics.
It was decided to offer this year's QP Forum also as a Live Online Conference (hybrid). All lectures and sessions of the main Forum will be held consecutively and can be attended by participants either directly on site in Berlin or live online. A first programme with three pre-conference sessions was finalised and published on the Qualified Person Forum website. Other speakers are invited.
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 conducted mid of January where the Activity Plan was prepared and the OOS Guide was discussed.
Chapter 3 of the OOS/OOL Guideline Dealing with Deviations in Sterility Testing was completed and prepared for publication after the European Microbiology Conference in May.
Take a look at the current courses & conferences programme in pharmaceutical microbiology.
Analytical Quality Control Group
Chris Burgess has been reappointed to the USP CoE GC-EC until 2025 and the new Joint Subcommittees for the revision of <1058> and finalisation of <1220>
Further, a board meeting was scheduled to take place Live Online on 23 June 2021; a second meeting is planned in November 2021.
The Group is also working on a Draft of a guideline on analytical instrument and system qualification, which was originally planned for 2020 and was postponed to 2021. It is also working on review outputs from USP <1220>, ICH Q2(R2) and Q14 in order to consider a revision of the APLM Guideline from 2018 and starting to plan the process for a new Guideline on Sampling.
Please also visit the current courses & conferences programme in analytical quality control.
After version 1.0 of the Group’s ECA Good Practice Guide on Integrated Qualification and Validation was published at a Launch Conference in October 2020, the Group plans to develop a version 2.0. The meetings of the task force developing this version 2.0 are conducted online. New subgroups handle the topics contracting, remote-FAT/SAT, and regulatory endorsement. The launch of version 2.0 is planned for November 2021. A full group meeting is planned in November 2021.
Find out more about the current validation courses & conferences programme.
European GDP Association
The next board meeting to take place as an online meeting was scheduled for June 2021.
New membership cards with a validity until end of December of 2021 were sent out to all GDPA members.
The new GMP and GDP Conference, the “European GMP & GDP Forum”, is scheduled to take place on 22, 23 and 24 June 2021 (Day 1: GMP Part; Day 2: GMP & GDP Part; Day 3: GDP Part). The forum was advertised accordingly. Travelling and face-to-face meetings are still difficult. Therefore, it was decided to offer this first GMP & GDP Forum live online.
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. The GDPA decided to share a selection of these Q&As sorted by topic. Parts 1 to 3 have already been published. Further Q&As are prepared to be published step by step. A combined Q&A document was created, which will be published in the GDPA members’ area of the website.
Get an overview of the current GDP events.
Visual Inspection Group
Felix Krumbein from Roche has become a new member of the ECA Visual Inspection Group
The next event of the Group is scheduled to take place online in November. The programme is currently being developed.
Andrea Hauser and Martin Hildebrandt had participated in a BTC meeting of the European Commission in Brussels some time ago. Another invitation to a stakeholder workshop in the beginning of May followed.
The Group set up a new online conference format: participants of the training course GMP for ATMPs can watch the streaming of recorded presentations for the event any time between 14 and 16 June and get their questions answered in a live expert Q&A and panel discussion on 17 June. The expert group for the Q&A and panel discussion was assembled
Please also take a look at the events programme conceontrating on ATMP topics.
Data Integrity & IT Compliance Group
The Group’s Data Integrity Guide new version 3.0 is currently being revised and scheduled for publication in the second half of 2021. In a next step the integration of Data Integrity in GLP is planned.
Here you will get to the courses and conferences focusing on data integrity & IT compliance issues.