Updates from the ECA Interest Groups
Every quarter the ECA’s Interest and Working Groups inform about their accomplishments and current activities. In the following you’ll find their report for the first quarter 2018.
European QP Association - Activities
In March the IMP Working Group met in Brussels to discuss the programme for their QP Forum pre-conference. In a meeting with EFPIA the Clinical Trial Regulation "labelling challenges" (Annex VI) was discussed.
The EQPA Board further forwarded their comments on the Revision of ‘Annex 1: Manufacture of Sterile Medicinal Products’ to EMA in early March – please also see the respective news.
The programme of the 13th QP Forum on 29-30 November in Prague, Czech Republic, has been finalised and placed on the market. So far, 26 speakers have accepted an invitation. Among them are six speakers from authorities, inspectorates and societies. More speakers are being invited. The programme is available on the QP Forum website.
The European Medicines Agency (EMA) asked industry associations throughout Europe to pass on some questions to their members to receive feedback with regard to the qualification of API manufacturers. The European QP Association therefore compiled a questionnaire for its members. The survey was conducted in January 2018. Altogether 245 members provided feedback. The results were summarised and sent to EMA end of January – and are posted in the members‘ area of the website.
Survey on Direct to Patient Shipments: Based on the evaluation forms of the IMP pre-Forum session, the presentation on On-demand packaging and Direct to Patient (D2P) shipments was well received and appreciated. Therefore the IMP Working Group invited the members to complete a survey on D2P shipments. The results will also be issued in the IMP section of the members’ area.
The EQPA was invited to join an industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products. This meeting was conducted in March. David Cockburn and Lance Smallshaw attended the meeting personally and Ulrich Kissel via remote. Meeting notes were circulated through the board members. EMA was clear on the just "agreed" draft withdrawal agreement between EC and UK. This agreement will not prevent UK to become a third country starting from 30th March 2019. Any other arrangements finally ratified will only become final during Q1/2019 and therefore will come too late to be considered in the companies´ and EMA´s strategies. It was very clearly recommended to prepare on the scenario of a hard Brexit.
Pharmaceutical Microbiology Working Group - Activities
The Board Members Björn Breth and Barbara Gerten had a first meeting to discuss the Q&A paper on culture media. This paper turned out to be more comprehensive than initially intended. For that reason this paper will only be available in fall at the earliest.
The first chapter of the Guideline document on Deviation Handling of microbiological Environmental Monitoring Excursions in non-sterile Pharmaceutical Manufacturing was finalized and scheduled to be introduced at the European Microbiology Conference scheduled in April. It will also be available in the Group’s website members’ area.
The Board Member Michael Nübling returned from the WHO to the Paul-Ehrlich-Institute.
Analytical Quality Control Group – Activities
The ECA QC Group’s Board set up two meetings for 2018: in April members will define and finalise their work plan 2018/2019, develop and agree workshop materials for the PharmaLab Congress in Dusseldorf in November 2018 as well as define their stability testing activity with EFPIA. In the November meeting it is planned to review the progress of the work plan 2018/2019, to collect APLM Guideline feedback and prepare for version 2, to follow up with the ICH Q2(R1) and USP progress following meeting in Rockville in September 2018 and to define a strategy and structure for the Sampling and Sample Management Guideline for 2019.
Validation Group - Activities
Draft 5 of the “Modern Qualification guide for fast track qualifications” was further discussed. There were regular telecons with an editing team. Another telecon was scheduled for May with the entire group. A respective conference on “Modern Qualification” is in the planning and scheduled for September 2018.
Other courses scheduled for the 2nd quarter: Process Validation in the light of Annex 15 and FDA-Requirements, Modern EU and FDA Validation: OPV/CPV from Control Strategy to PQR.
European GDP Association – Activities
A meeting was held with PQG to complete the GDP Interpretation Document. It was agreed that PQG requests quotation for printing and type setting etc. and finalise the document for print. This document is supposed to be introduced at the GDP Conference.
The idea of a survey on GDP implementation conducted by the European GDP Association in November/December 2017 was to find out what the current status of implementation with regard to Good Distribution Practices at wholesalers and pharmaceutical manufacturers is. Altogether 98 persons responded to the questions. The summarized results are available in the download section of the members’ area on the GDPA website.
Visual Inspection Group - Activities
The Group’s chairman Tobias Posset is official member of EDQM’s Expert Group 12. The revision of the Ph. Eur. 2.9.20 (including an appendix for explanation) has been started. ECA’s feedback is included within the new Pharmacopeia wording. The next meetings of Group 12 are scheduled for April and September.
The Group meeting 2018 has been scheduled for October in Hamburg before before the ECA conference ‘Particles in Parenterals’. The programme for the conference was further discussed; finalization are supposed to be early in Q2 2018.
ATMP Group - Activities
Early in the quarter the latest of the ECA Foundation’s Interest Groups published their website. In addition to the contents from the AGORA website it now provides a number of guidelines. All AGORA members were addressed and invited to join the new group – so far almost 100 persons joined.
The new Group’s Board – also comprising two representatives from the Paul-Ehrlich-Institute, the German Federal Agency for Vaccines and Biomedicines – will get together for its first meeting end of June – just prior the first GMP for ATMPs Conference in Berlin, Germany.
IT Compliance Group - Activities
End of the first quarter the Group issued version 2 of their “Data Integrity Guide” (please also see the respective news.
The development of a Data Integrity Toolbox was discussed as well as an e-compliance-Initiative.