Updates from the ECA Interest Groups

What the ECA Foundation's Interest Groups were working on and accomplished in quarter 3 2019 you can read in their Q3 2019 report.

European QP Association - Activities

The IMP Working Group leadership team met end of July in Brussels to discuss and plan the IMP Sessions for the QP Forum as well as the team’s future structure.

The EQPA‘s Good Practice Guide "Duties and Responsibilities for Qualified Persons in the EU" also comprises an Annex providing information on the individual EU member states' requirements for becoming a QP, on the functional area requirements/specifics, on interest groups in the country and on its authorities. To update this Annex, members were asked for support.

A survey on Quality by Design was sent out to EQPA members. This survey was designed by Maria Papantoniou, postgraduate at De Montfort University in Leicester, UK, and aimed to help in assessing perceived positives and negatives as well as the level of implementation of Quality by Design in the EU. A total of 186 provided feedback, which was summarised by Maria in an article and published in the EPQANewsletter.

The EQPA prepared a list of topics to be brought forward into the IWG (lists from all interested parties co-ordinated by EFPIA further consolidation). Topics include:

  • Annex 21
  • will art.111.1 of Directive 2001/83 be properly implemented after Brexit?
  • Role of QP in Serialistaion
  • Role of QP in acceptance of import testing under US/EU MRA
  • Harmonisation of QP Qualification
  • QP for Biotech APIs

In a discussion with other industry associations, common topics were identified to forward to EMA for a possible EMA-IWG meeting. The goal is to align the interested parties and to focus on key topics to communicate to EMA-IWG in a letter in October asking for a targeted meeting, webinar and/or a written response. EQPA is supposed to lead the following potential topics:

  • GAP for inspections caused by BREXIT
  • Clinical trial directive: development of the CTIS – timelines
  • QP related topics (Serialization, QP responsibilities: Annex 16 implementation, Qualification of QPs, QP certification in Biotech API manufacturing plants)

EQPA will also support other possible topics: Annex 21, Inspections in the framework of FMD, Annex 1 and MRA EU/US Implementation.

European QP Association website

Pharmaceutical Microbiology Working Group - Activities

In a Kick Off Meeting the new established PEI/ECA - MAT Task Force created a document, which was spread for comments. In the following two telcons comments were discussed, and the paper was finalized mid of September.

The Board considered an extension by 1 or 2 members or assessors, giving the growing area of CLOs a voice on the Board. A meeting for November was scheduled.

Chapter 2 of the OOS/OOL Guideline Handling Deviations in Endotoxin Testing - CRL internal review was completed. The Board agreed to review until November meeting where the chapter was supposed to be finalized.

Pharmaceutical Microbiology Group website

Analytical Quality Control Group - Activities

Analytical Quality Control Group website

Validation Group - Activites

The Group’s Draft Good Practice Guide Modern Qualification was revised – and a second draft version was prepared to be launched at a Launch Conference in October. For this purpose the editing team was distributed in sub-groups: red threat group, PQ/PV group, equipment categorisation group, conference group. Developments were discussed in regular telcons of the sub-groups and in face to face meetings with the full group.

An Initiative was started to set up a sub task group dealing with electronic record/digital documentation in qualification/validation projects, which means everything contrary to handwritten paperwork. More details were to be provided in the next face-to-face meeting in October – to come up with a decision for this new sub-group; also to make sure there is no overlapping with other groups (IT) or documents (Data Integrity document)

Validation Group website

European GDP Association - Activities

The Board was extended by a new position – Director of Regulatory Affairs and Communication. The main tasks for this role are to keep up to date with the regulatory changes ensuring the board is aware of all new GDP regulations. The role is also supposed to act as the main communication point internally and externally via preparing newsletters, web-blogs, etc. on behalf of the board. Prabjeet Dulai, a Consultant Responsible Person at GDP & Quality Matters Ltd., was nominated for this new position.

The project with PQG to create a guidance document for interpretation and implementation of the GDP requirements for APIs is well on track. The combined draft document was reviewed and edited and circulated for final review.

The European GDP Association received a copy of a slightly revised draft of the new GDP guidelines developed by WHO for review and comment. Comments were due in September. Afshin had reviewed and commented the pre-release version of the document in Q2 2019 – and some of these comments had already been taken into account. The Board Members reviewed the document again – and Afshin compiled all comments and returned a single response from GDPA.

The European GDP Association has been invited to present at the GDP conference in Belgrade organised by the Belgrade University and the local pharmaceutical association (April 2020). Prabjeet Dulai represented the GDPA and gave the opening speech and a short presentation about the European GDP Association.

European GDP Association website

Visual Inspection Group - Activities

The updated version (3.1) of the best practice guidance on visual inspection was published on the group’s website – and prepared to be handed out during the Visual Inspection event in October.

The group is waiting for the finalisation of the Annex 1 and will then decide on further updates of the ECA Visual Inspection guidance document.

The update of the Position Paper on Container-/Closure Integrity Testing was scheduled for the Board meeting in October.

Visual Inspection Group website

ATMP Group - Activities 

The change at the top of the Group Leadership was completed. Sabine Hauck took over as Chair, Andrea Hauser became Vice Chair.

In addition the ATMP session at PharmaLab in November was prepared. Group members further answered technical questions.

ATMP Group website

IT Compliance Group - Activities

A new Guide “DI in clinical trails” as part of the ECA DI Guide was further developed.

IT Compliance Group website