Updates from the ECA Interest Groups
In the following you will find out what the ECA Foundation's Interest Groups were working on and accomplished from April through June 2019 - in their Q2 2019 report.
European QP Association - Activities
The IMP Working Group has sent out a question with regards to the use of Interactive Response Technology (IRT) to manage the use-by date in early clinical phase. EMA’s “Reflection paper on the use of IRT in clinical trials, with particular emphasis on handling expiry dates” outlines what National Competent Authorities expect from such systems. Appendix I to this reflection paper provides a “QP declaration template on use of IRT in the event of use for handling expiry dates” for IMPD submission.
The Working Group is still interested in gathering more collective experience of the IMP QP members and is specifically interested in learning which European countries accepted IRT management of use-by dates including the IRT QP declaration and thus currently accept that no expiry date is printed on the label.
The programme for the The Qualified Person Forum 2019 was completed. With Silja Du Mont, GCP/GDP Inspector from Germany, one more inspector has accepted the invitation to speak at the conference.
Pharmaceutical Microbiology Working Group - Activities
Chapter 2 of the OOS/OOL Guideline is still in the review process - Dealing with deviations in testing for endotoxins
The date for the next board meeting was fixed and will take place on 11 November in Neuss. In April it also set up a MAT Task Force
The group conducted a Bioindicator Workshop and the European Microbiology Conference as well as two webinars. It was also decided that the MAT course will be repeated in 2020.
Analytical Quality Control Group - Activities
The update to version two of our APLM Guideline is currently planned when either ICH Q2 & Q14 reach step 2 which may be 2021 and/or USP General Chapter <1220> is developed further and published in Q4 2019 or Q1 2020. However, as part of our ongoing education and data gathering initiatives, the AQCG are running a 2 day Workshop on ‘Analytical Procedure Lifecycle Management /Revisions to ICH Q2 & the proposed Q14’ as part of the PharmaLab Congress being held on 12th and 13th November 2019 in Dusseldorf.
The board of the group has been extended to include Dr Bob McDowall who will lead the development of a new guideline to support the APLM. This guideline will cover analytical system and instrument qualification which is an essential prerequisite for the Analytical Lifecycle. It is intended to be in a draft form by the end of 2019.
The Group intends also to look at developing other prerequisite guidelines as time and resources permit.
The Group hope that there will be good support at the Congress and any members wishing to be involved in Guideline development may use the contact form on the Group website.
Validation Group - Activities
The group’s draft Good Practice Guide Modern Qualification is currently being developed to a final version. This final version will be launched at the Launch Conference on 8/9 October 2019. For this development the editing team was split in subroups: red threat group, PQ/PV group, equipment categorisation group, conference group. There are regular telecons with the subgroups and face to face meetings with the full group (coming meetings planned for early June and early October before launch conference).
One of the task force members initiated to set up a sub task group dealing with electronic record/digital documentation in qualification/validation projects – which means everything contrary to handwritten paperwork. At the next face to face meeting more details will be discussed – taking into account that there will not be any overlapping with other groups (IT) or documents (Data Integrity document).
European GDP Association - Activities
The group has reviewed the new WHO GDP document. In general it is seen to be a good document. However, the many references to subjects only relevant in the manufacturing areas rather than to the supply chain – where this should be focusing – suggests that it was written by GMP professionals. The comments were sent to WHO.
The project with PQG to create a guidance document for interpretation and implementation of the GDP requirements for APIs is well on track. A combined draft document has been created for review and editing.
Together with Concept Heidelberg, the planning for the 2020 GDP Conference (“GDP Forum”) started. Firs speakers were already invited.
Visual Inspection Group - Activities
The updated version (3.1) of the best practice guidance on visual inspection was published im the Visual Inspection Group website in May.
The group is waiting for the finalisation of the Annex 1 and will then decide, whether the ECA Visual Inspection guidance document hast to be further updated or not.
The next board meeting was scheduled to take place on 8 October in Vienna.
ATMP Group - Activities
Dr Hauser, the group’s chairman, has taken on a new function in the clinic she works for. Due to her new commitment, the board decided that Sabine Hauck, who previously acted as deputy chairwoman, will take over the chairmanship and Dr Hauser will change to the deputy position.
The survey from previous fall was updated and put online again and sent to all participants. A reminder is planned end of summer.
A round table was conducted in June in Vienna, with almost 20 participants. Represented were the authorities from Norway, the Netherlands, Belgium, Austria and Germany. The summary is currently in review, but will soon be available, as well as a short conference report about the conference end of June in Vienna with a total of 72 participants.
An ATMP session was planned for November as part of PharmaLab.
IT Compliance Group - Activities
The board initiated a new Guide “DI in clinical trails”.
A Data Integrity Conference was conducted as part of the Pharma Congress 2019 in April.
The ECA was invited by PIC/S to comment the draft of PI 041 on Data Integrity. For that purpose the group organised a workshop end of February 2019. Comments from this workshop as well as other feedback was collated and forwarded to PIC/S – and are available in the DI & IT Compliance Group website.