ECA Foundation

Updates from the ECA Interest Groups


To accomplish its goals the ECA Foundation established a number of working and interest groups in the last years. Inviting industry and authority professionals to get actively involved these groups are driving various activities in specific areas – like organising training themselves, conducting surveys to provide feedback to guideline drafts, writing Good Practice Guides or white papers and much more. In the following you will find brief summaries of the group's activities and accomplishments.

European QP Association
The group is marked through constant growth. By today it has more than 2.400 members from over 40 countries. In late 2015/early 2016 there were some changes in the EQPA's Advisory Board:
  • Dr Christopher Burgess stepped down end of 2015.
  • Edit Szocs who had joined the Board in 2013 as a representative of the Hungarian National Institute of Pharmacy and Nutrition (NIPN) left the agency end of 2015 and thus also resigned from her appointment in the EQPA. Mag. Pharm. Andreas Kraßnigg from the AGES, the Austrian Agency for Health and Food Safety, took her position on the authority side.
  • Tor Gråberg, Chief Pharmaceutical Inspector and Head of Drug Inspectorate at the Swedish Medical Products Agency (MPA), has been member of the Advisory Board since 2014. Tor also left the agency end of 2015 and is now with AstraZeneca. He remains on the Board, though.
  • The QP Association also announced a change in its IMP Working Group’s leadership team. Succeeding Geneviève Meeus from Johnson & Johnson is Brenda Van Assche.
Activities:
  • On 15 June the EQPA's IMP working group met in Brussels. The main focus of this working group meeting was on interaction with regulatory authorities and recent guidance issued for comments, an update from the QP to QP agreement task force and an intensive discussion around the set-up for the IMP Pre-conference and IMP parallel session for the upcoming QP Forum 2016 in Madrid.
  • A survey was conducted to understand whether contract givers are completely mirroring the PQS of the contract receiver. This survey was developed together with Deirdre Dunne, a student studying at Trinity College in Dublin, Ireland for an MSc in Pharmaceutical Manufacturing Technology (the QP Course). Altogether 361 members responded (very good number). Deirdre Dunne evaluated the outcome and provided a summary which is available in the website members' area.
  • As the Brexit will also have implications for the QP's function the group published a statement “What does Brexit mean for the QP?” prepared by the lead-team in July.
  • In September the results of another survey “The complexity and challenges of the management of global product release scenarios” were published in the members’ area.
European QP Association website
Pharmaceutical Microbiology Working Group
Originally established as Rapid Microbiological Methods (RMM) Group, it was renamed to Pharmaceutical Microbiology Group in 2016. Only this year it gained 30 new members and now represents close to 470 members.

Activities:
  • New website issued end of July 2016.
  • The Group conducted its meeting in November within the frame of PharmaLab; new meeting planned for November 2017 at PharmaLab again.
  • Complete revision of the literature and publication list in the members area relating to the new covered topics of the group.
  • Joint Workshop with the German Paul-Ehrlich-Institute as 10th anniversary event of the group foundation meeting at the PEI in 2006 was organised in September 2016.
  • Support of EDQM Survey on new General Chapter on microbiological Control of Tissue in July 2016.
  • European Microbiology Conference scheduled in May 2017.
Pharmaceutical Microbiology Group website
Analytical Quality Control Working Group
Activities:
  • Version 01 of the Laboratory Data Management Guidance Out of Expectation (OOE) and Out of Trend (OOT) Results was available for the participants of the OOT Forum 2015 (Barcelona, December 2015).
  • Updates (new calculations for some of the equations) were implemented, and SOP made available in the ECA website members' area - just in time for the next ECA Education Course „Handling OOE and OOT Results“ in Prague mid of November.
  • Currently in contact with Chris Burgess to define the Advisory Board and to offer Membership to the group (still a working group). New activities have been identified by Chris.
Validation Group
In 2016 the number of group members rose to 330.

Activities:
  • Annex 15 Conference was set up and will be conducted in Hamburg, Germany, in February 2017.
  • A survey evaluated the interests of the group members to advance the group; results were published in the ECA Newsletter in November.
  • The group's further development was subject of a meeting between the group's Chair Gert Moelgaard, Oliver Schmidt and Sven Pommeranz, administrators at Concept Heidelberg end of September 2016.
Validation Group website
GDP Association
This group was founded in March 2013 – then as GDP Interest Group. In November it was transferred to an Association and by today counts 1.800 members.

Activities:
  • In cooperation with the PQG the GDP Interpretation Guide was finalized. All chapters are available online for the members.
  • A Code of Practice for RPs was developed (very similar in the structure to the Code of Conduct for QPs). The current version is available in the website's members' area.
  • The discussion forum gets more and more attention.
  • A GDP Conference will be held in 2017 and might be repeated every year or every two years (with different topics).
  • A new Board was formed under the leadership of Afshin. Martin Egger, Pharmserv, Christian Grothe-Westrick, B.Braun Avitum and Sue Mann are involved. From the authority side Johanna Linnolahti from the Finish Inspectorate supports the group.
GDP Association website
Visual Inspection Group
Established in 2013 the group reached a new record in group memberships in 2016: more than 1.400 in total. The group's meeting was conducted as part of the ECA Particles Conference in Barcelona in September.

Activities:
  • New Q&A Document published on the group website in September.
  • Version 3 of the Best Practice Guide on visual inspection was finalised and also presented during the Particles conference.
  • The revised Guidance document has been made available on the website for the whole group.
Visual Inspection Group website
IT Compliance Group
This group was founded end of 2014 and now counts over 250 members.

Activities:
  • Best Practice Papers on Cloud Computing (SOP / Audit questions) finalized.
  • Additional papers on Cloud Computing (discussion going on – publication possibly early 2017 before the next Cloud Computing course).
  • Planed project on Audit Trail Review postponed / cancelled. The topic will be discussed in the new DI guide.
  • Cooperation with the AQC group on Data Integrity.
  • Discussion of new activities – June 2017.
IT Compliance Group website

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