Updates from the ECA Interest Groups
Please read what the ECA Foundation's Interest Groups were working on and accomplished in the first quarter 2019 - in their Q1 2019 report.
European QP Association - Activities
The EQPA has finalised the Position Paper “QP responsibilities in the implementation of safety features (as per Directive 2011/62/EU)” aligned with EIPG. The main purpose is to clarify that the QP has no responsibility on electronic data handling/management after certification related to serialization. The paper was also discussed at an EMA-IWG Interested Parties teleconference on 16 January. It is available for EQPA members in the download section of the website.
Using Interactive Response Technology (IRT) to manage the use-by date is especially helpful in early clinical phase when there is limited stability data available, e.g. biological IMPs, ATMPs, refrigerated or frozen IMPs. 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 IMP Working Group asked the IMP QP members 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 published (27-29 November 2019, Munich).
Pharmaceutical Microbiology Working Group - Activities
In February the group conducted a joint PEI/ECA Workshop on Validation RMM in Ph. Eur. - with representatives of EDQM, BfArM, AEMPS (Spain), Agency for Medicinal Products Slovenia, AGES (Austria), DMA (Denmark), IMA (Iceland), ANSM (France), MMA (Serbia), Urzad Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (Poland) NMA (Norway) and industry representatives (summary to be prepared by PEI). It also held the first MAT course, a hands-on lab course which was completely booked.
The Board further met to kick off the MAT Task Force. This kick-off was scheduled for early April at the Paul-Ehrlich-Institute in Langen, Germany.
The group also reviewed Chapter 2 of the OOS/OOL Guideline - Handling Deviations in Endotoxin Testing.
Moreover, the programme of the European Microbiology Conference was published – the conference will take place from 8-9 May in Barcelona, Spain.
Validation Group - Activities
The group worked on the development of a final version of the ECA Draft Good Practice Guide Modern Qualification. For this development the editing team was split in subgroups: red threat group, PQ/PV group, equipment categorisation group, conference group. There are regularly telecons with the subgroups.
European GDP Association - Activities
For the first time exclusive membership cards for the European GDP Association members where issued. Cards are valid for one calendar year.
On behalf of the Advisory Board, Prabjeet Dulai has revised the Roadmap to GDP document. The European GDP Association has compiled this document to support pharmaceutical and wholesaler businesses in implementing regulatory requirements and expectations in their quality systems. In addition it provides checklists to verify the minimum implementation of GDP. The document is available for download in the members' area on the GDP Association website.
The Association has started a project with PQG to create a guidance document for interpretation and implementation of the GDP requirements for APIs. Work started in November 2018, with the aim to have the new document published in November 2019. Different project teams were formed to work on the individual chapters. The first set of chapters has already been finalized.
Visual Inspection Group - Activities
The next Board meeting has been scheduled to take place in October 2019.
An updated version of the best practice Guidance on visual inspection will be published in the 2nd quarter 2019. The updated version will comprise editorial changes and clarifications.
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.
ATMP Group - Activities
In March the group conducted a telcon of the Board with the purpose to develop a coordinated ATMP strategy. The next Board meeting was scheduled for June 2019.
To evaluate the current challenges and problems that arise during production, control, quality assurance and approval the group had conducted a survey on the potential challenges and hurdles related to GMP for ATMPs at the end of 2018. In a next step the group approached these issues by organizing a round table discussion with experts from regulatory bodies, academia and industry to discuss possible solutions to selected topics concerning GMP for ATMPs. This roundtable discussion is scheduled for June. Currently there are preliminary commitments by PEI, AGES, Belgium, Netherlands.
A specific conference on GMP for ATMP Products will take place in June 2019.
IT Compliance Group - Activities
The development of a Data Integrity Toolbox is still planned for Q2 2019. The first documents were discussed with a few Board members.
The group (as part of the ECA Foundation) was invited by PIC/S to comment their draft of PI 041 on Data Integrity. For that purpose the ECA and members of the interest group organised a workshop on to comment the document.
A DI Conference is scheduled to take place in Q4 2019.