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 fourth quarter 2017.
European QP Association - Activities
In December the EQPA Board of Directors met in Budapest. Richard Bonner officially stepped down as chairman and member of the board. Ulrich Kissel was officially appointed as his successor as Chairman. Furthermore, Georg Göstl from Shire and David Cockburn (formerly with EMA) were officially nominated as new board members.
To prepare the IWG Interested parties meeting, an inter-association telecom was held in October. Present were representatives of EBE, Medicines for Europe, AESGP, PDA, APIC, EIPG, EFPIA, IFAH, EQPA and ISPE. A follow-up telecom in November was supposed to prepare the meeting with GMP/GDP IWG scheduled in December. Tor Gråberg attended the GMP/GDP IWG meeting with Interested Parties on 6 December 2017 on behalf of the EQPA board. His meeting notes are available in the members’ area.
The 12th QP Forum was held in Budapest, being a great success. More than 250 participants and 29 speakers met over three days to discuss QP relevant topics. The ratings of the various parts were very good
Based on the QP tasks listed in Annex 16 sections 1.7.1 -1.7.21 and Annex 13 section 40, the IMP QP Working Group developed a questionnaire on Delegation – trying to find out the current approach to the delegation of QP tasks 'as is'. The Task Force “to delegate or not to delegate” sent out the survey in early December. Results are supposed to be available in the IMP Working Group’s members’ area in February 2018.
In December the EMA further conducted a webinar entitled “Brexit related manufacturing and supply".David Cockburn participated in this webinar. Its goal was to mainly answer questions sent in by stakeholders. David provided a summary of the questions asked by the industry associations and answers provided by the EMA. These Q&As are available in the download section in the members’ area as well.
European QP Association website
Pharmaceutical Microbiology Working Group - Activities
The group’s Advisory Board met in November. There the following issues were discussed:
- The European Microbiology Conference and a Data Integrity in Microbiology Programme were drafted.
- The Annual Board Meeting has been scheduled on 6 November in Neuss, Germany.
- A workshop for regulators on the awareness of automated systems for microbiological laboratories was considered and will possibly be conducted.
- The guide for the handling of microbiological excursion in EM in non-sterile manufacturing was prepared and reviewed by some external experts. The final version is supposed to be distributed to the group members.
- Information on common requests and problems with culture media was gathered. These issues are supposed to be grouped and formulated in 2-3 questions with their responses (until end of January 2018). The group will then review this draft (until end of February 2018). Until end of March 2018 a revised version will be published. This will be a living document and further issues/question will be added in the future
- The group performed a brainstorming on the strengths and weaknesses and partially on the opportunities and threats. This SWOT analysis will further be developed to identify a maximum of 4 topics as a proposal for an action plan for the future direction/topics for the group. The group plans to give the feedback on this proposal until end of February 2018.
Events in the quarter included the Microbiology Pharmaceutical Update, RMM/Mycoplasma Conference, Microbiologcal Quality of Medical Devices, Contamination Control, EM Data Management
The first chapter of the OOS Guide was finalized.
Pharmaceutical Microbiology Group website
Analytical Quality Control Group – Activities
The ECA QC Group met for the 2nd AQCG Board Meeting in October where the further development of the Guideline “Analytical Procedure Lifecycle Management” was discussed.
This Guideline was launched during a workshop at the Analytical Procedure Life Cycle Conference in November. The conference also provided the opportunity to discuss it and provide comments and feedback to establish the final version.
Analytical Quality Control Group Website
Validation Group - Activities
There were two additional meetings (September and November) with ECA´s Qualification and Validation Task Force. A 3rd draft of ECA “Modern Qualification guide for fast track qualifications” was reviewed and will be revised. Revised chapters are supposed to be shared in December. The next meetings 2018 were fixed (February twice and April). At the February date also the first programme draft for an ECA Modern Qualification conference (planned for Sept 2018) will be discussed.
Courses about Cleaning Validation, SPC, Process Validation (2x), Ongoing Process Verification and Validation Manager Course for 2018 were available on the market.
European GDP Association - Activities
The Advisory Board nominated a new board member to represent global pharma industry: Saddam Huq, GlaxoSmithKline, U.K., who is Global QA Senior Manager Quality for Distribution & Cold Chain Management Vaccines, Quality Assurance Shared Services at GSK. Before that Saddam Huq was Cold Chain Technology Head at Pfizer.
On behalf of the Board of Directors, Wolfgang Schmitt gave a presentation at the Seoul Cold Chain Forum end of October. It was hosted by the Korea Conformity Laboratories (KCL) and the Korea Food Cold Chain Association (KFCA) and supported by the Korea Ministry of Trade, Industry and Energy and some other Associations. The aim of the presentation was to introduce European GDP Guidelines and the work of the European GDP Association. The delegates but also the organisers were impressed by the work and the support of the GDP Association to its stakeholders.
A Questions & Answers document was prepared on Chapter 1 QUALITY MANAGEMENT of the EU Good Distribution Practice Guideline and published on the GDPA website.
European GDP Association website
Visual Inspection Group - Activities
- The group meeting took place mid of October in Vienna with great success. In total 98 participants came to Vienna to one of the three conferences
- The meeting minutes of the board meeting were shared
- The organisation for the group meeting in 2018 has started. A call-for-papers was sent to all group members in November. The meeting itself was scheduled to take place from 9-11 October 2018 in Hamburg.
- The group’s chairman Tobias Posset became 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 and the ECA feedback is included within the new Pharmacopeia wording. The next meetings of Group 12 will be held in April 2018 and September 2018.