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 second quarter 2018.
European QP Association - Activities
The programme for the QP Forum 2018 was almost complete. With a MHRA and a HPRA representative, two more inspectors accepted the invitation to speak at the conference.
The EMA updated their template for GMP non-compliance statements for manufacturers after inspections. One major driver was the intent to provide clarity and support in such matter to the QPs. The EQPA wanted to provide feedback to EMA on the basis of a few questions. Therefore a survey was conducted to evaluate the QPs’ expectations and needs. Altogether 77 colleagues provided their feedback. The results are available in the members’ area.
End of April the European Medicines Agency (EMA) issued the draft of the Guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice. The public consultation started end of May. The IMP Working Group of the European QP Association plans on submitting consolidated comments, and asked EQPA members for Feedback.
EQPA was contacted by the Bulgarian QP Association and asked for support (use of same website; shared conferences). However the European QP Association’s approach is to focus on an overall and common European approach. A few years ago it was decided not to set up any national chapters under the umbrella of the EQPA. And there is only an informal co-operation between the EQPA and the Austrian and German QP Associations (based on the exchange of information).
Pharmaceutical Microbiology Working Group - Activities
The first chapter of the Guideline document on Deviation Handling of microbiological Environmental Monitoring Excursions in non-sterile Pharmaceutical Manufacturing was introduced at the European Microbiology Conference in April. It was also made available in the Group’s website members’ area.
The first chapter of an OOS/OOL Guide has been completed. Further, Q&As on culture media are in progress.
The planning for a joint ECA/PEI workshop on system validation was started. A telephone conference is scheduled for early August.
Analytical Quality Control Group – Activities
During the workshops at the Analytical Procedure Lifecycle Management (APLM) Conference end of November 2017 delegates had the opportunity to provide comments. These comments have been incorporated to set up the first final version of the Laboratory Data Management Guidance about Analytical Procedure Lifecycle Management (APLM). It is the aim to distribute this APLM Guidance to a selected audience (FDA, USP, EFPIA, etc.) and to launch it at the PharmaLab Congress on 20 November 2018 in Düsseldorf/Neuss.
From 24-26 April the AQC Group’s Board met in Frankfurt where the work plan 2018/2019 and the Guideline for Analytical Procedure Lifecycle Management were reviewed. Workshop materials for the Pharma Lab Congress scheduled in Düsseldorf/Neuss on 20 November 2018 were also developed there.
The next face-to-face meeting of the Board has been scheduled for November during the PharmaLab Congress. There, feedback to the APLM Guideline will be collected to prepare for version 2, and it is planned to follow up on the ICH Q2(R1) and USP <1220> progress after the meeting in Rockville end of September. Further, during this Board meeting it is also planned to set up a strategy and structure for Sampling and Sample Management Guideline for 2019.
Validation Group - Activities
Draft 5-6 of the “Modern Qualification guide for fast track qualifications” was further discussed in regular telecons with the editing team. Further, the entire group met in a face-to-face meeting on 21 June. A first public draft will be distributed during the respective conference on “Modern Qualification and Validation” scheduled for September 2018.
A survey on qualification and commissioning is further planned to support ECA´s Modern Qualification and Validation Conference.
European GDP Association - Activities
A Board meeting was held in early June in Barcelona. A report with actions was finalised and circulated among the members.
The GDP Interpretation Document was finalised ready to print. Together with PQG it was decided to charge £40 per copy, with a 30% discount for the PQG and ECA GDP Association members. A discount code can be found in members’ area. Free copies were available for participants of the GDP Conference in June.
PQG is currently also preparing a PDF interactive format of the document for the websites (to be published in members’ area of the GDP Association). The also agreed to send a pdf version of the GDP Interpretation Document to the competent authorities.
On 5/6 June, the 2nd GDP Conference was held in Barcelona. Altogether 76 delegates from 22 countries joined – and rated the conference with 1.6 (1 = very good, 6 = bad).
Visual Inspection Group - Activities
The next Board meeting has been scheduled before the ECA conference ‘Particles in Parenterals’ which will take place from 9-11 October in Hamburg.
Once Annex 1 will be final the Group will decide whether the ECA Visual Inspection Guidance document hast to be updated or not.
ATMP Group - Activities
The Group conducted their first Board meeting end of June where the future orientation and the business plan 2018/2019 were discussed. A telephone conference was scheduled for end of July where the respective conference in 2019 will be discussed and the planned survey will be finalised.
The Group was also represented at the “stakeholder consultation meeting at the European Commission in Brussels on June 14, 2018 regarding the revision of the blood directive (2002/98/EC) and the tissues and cells directive (2004/23/EC)”.
At PharmaLab 2018 (20/21 November in Düsseldorf/Neuss) an ATMP Session has been planned for the German speaking part. Further, planning for an expert industry/authority workshop as well as for a GMP for ATMP education course in 2019 are in progress.
IT Compliance Group - Activities
The development of a Data Integrity Toolbox was discussed. The first documents were discussed with a few Board members. A first version is planned to be available in Q3/4.