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 2017.
European QP Association
- Update on membership numbers: more than 2.500
- The IMP Working Group within the European QP Association sent in their comments on the Commission Delegated Regulation on GMP for IMPs to the EU Commission. The IMP Working Group appreciates the ongoing revision of GMP guidelines for IMPs in the context of implementation of the Clinical Trial Regulation. However, as many other stakeholders, the Working Group recommends to implement the new regulations as much as possible into the existing GMP guidance. Thus, it would be easily possible to even add newly developed GMP Guidance, e.g. for ATMPs (both commercial and IMP) through another Annex. In its comments, the group gives clear examples how this could be achieved. The comments in detail are available on the EU Commission website.
- A Survey was conducted to gather feedback on the release of medicinal products impacted by a statement of non-compliance. More than 410 EQPA members returned their feedback. Results are available in the members’ area on the EQPA website.
- The EQPA provided input for an article in the PinkSheet on the revised guidance issued by the CMDh on QP Declarations.
- The program for the QP Forum (30 November – 01 December 2017 with pre-course sessions on 29 November) was finalised and the QP Forum website was updated.
Pharmaceutical Microbiology Working Group - Activities
- 37 new members in the first Quarter 2017, increasing membership numbers to more than 500
- The guidance document for deviation handling in non sterile manufacturing was finalized and sent out to the Board Members for comments
- Planned USP Session in November was enhanced with EDQM to a general Pharmacopoeial session – USP will send 3-4 speakers, EDQM 1-2 speakers
- New course on microbiological testing of MD is finalized
- New course on handling of EM data is finalized
Analytical QC Group – Activities
- Update on membership numbers: more than 130
- The members of the QC Group met for the 1. AQCG Board Meeting to discuss the next steps of the group. In addition the actions required for the new group website was discussed
Validation Group - Activities
- New record of the number of group members in April 2017: 668 in total
- In a Board Meeting the development of the group was discussed. It is proposed to organise an regular event as “meeting point” for validation people.
- Start up meeting for the new ECA Qualification and Validation Task Force at PharmaCongress (End of March 17). The goal of the task force is to develop qualification templates which are useful for suppliers and the pharmaceutical industry. The next meeting is planned for end of June 2017. Potential members of such a group will be contacted.
- Courses about Cleaning Validation, SPC, Process Validation (2x), Ongoing Process Verification and Validation Manager Course for 2017 and beginning of 2018 on the market available.
- A validation session will be conducted at 7th GMP Conference, 30 May/1 June 2017 in Prague. Klaus Eichmüller, member of the IWG that revised the Annex 15, will give a short overview about the current status of implementation of Annex 15 in the pharmaceutical industry.
European GDP Association – Activities
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.
- Update on membership numbers: more than 820
- Dr Laura Ribeiro from ID Logistics in Portugal was nominated as new member of the Board
- In cooperation with the PQG the GDP Association intends to publish the joint GDP Guidance document in a final version (currently only single chapters have been published)
- A survey among the members and a Question & Answer document on GDP is planned
Visual Inspection Group - Activities
- Update on membership numbers: close to 1.500
- Programme and agenda for the group meeting at Particles in Parenterals Conference in October have been finalised and forwarded to the group members.
- The ECA Visual Inspection Paper has been sent to PIC/S and was forwarded to the respective working group within PIC/S for informational purposes.
- The work on the position paper concerning CCIT is still ongoing. Comments from the Board Members are pending. Proposed finalisation is before the group meeting in Vienna, October 2017.
- First contact with EDQM expert panel for the EP chapters on visual inspection.
IT Compliance Group – Activities
This group was founded end of 2014 and now counts over 250 members.
- Update on membership numbers: 300
- The Board Members currently discuss potential developments/options for the future (like a “toolbox” for Data Integrity with Templates, Checklists etc). A further meeting is planned for end of May