Updates from the ECA Interest Groups
The ECA Foundation's Interest Groups regularly inform about their accomplishments. What they were working on in the last quarter 2018 and what they accomplished is summarized in their report
European QP Association - Activities
The ECA Good Practice Guide No. 2 "Duties and Responsibilities for Qualified Persons in the EU" was amended and published on the EQPA Website – now additionally comprising the new chapters Qualification and Validation as well as QP and RP Interface.
The 13th QP Forum was held in Prague on 29/30 November with three pre-conference Sessions on the 28th. More than 250 participants and 30 speakers met to exchange experiences with colleagues and to establish contacts and networking possibilities.
EQPA conducted another survey to get an overview about QP Liability and the possibilities for insurance. The results were summarized and published in the members' area on the website. Publication in the EQPANews will follow.
The results of the survey asking respondents to describe approaches to the delegation of QP tasks according to Annex 16 sections 1.7.1 -1.7.21 and Annex 13 section 40 were published in the download area of the IMP Working Group. A report on this survey was also part of the latest EQPANews issue.
Together with EFPIA and other industry associations, the EQPA Board Members Dr. Ulrich Kissel and Georg Goestl forwarded a letter to EMA addressing the EMA announcement to cancel the EMA-IWG-IPM. This letter’s intent is to emphasize that stakeholders see the need for discussions to continue – irrespective of the cancellation of the IWG meeting with EMA and the continuity plans of EMA. In an answer to this letter, EQPA was invited to attend a telecon with EMA secretariat and other associations for 16 January 2019 to discuss a status update.
A new section of the website summarizes “Brexit”-related information relevant for QPs in a so called “Brexit Corner”.
Pharmaceutical Microbiology Working Group - Activities
The Board met in November where a new MAT Task Force was initiated. Members also discussed a joint PEI ECA Workshop there, which is supposed to take place in February 2019. The next Board meeting was scheduled for May and November.
The group also completed the programmes of the European Microbiology Conference and on Bioindicators as well as for a new MAT hands-on course.
Analytical Quality Control Group – Activities
The new APLM Guidance was further distributed to a selected audience (FDA, USP, EFPIA, etc.) prior to the official launch at the PharmaLab Congress on 20 November 2018 in Düsseldorf/Neuss.
The Board met at the PharmaLab Congress for the next face-to-face Meeting.
Validation Group - Activities
During the last Task Force meeting the group decided to develop the Draft Modern Qualification Good Practice Guide. To better manage the update, the Task Force was split into the subgroups review team, 'red thread' team, equipment category team, process validation (PQ/PV) team and the conference team.
The Guide was also distributed to a selected audience (FDA, USP, EFPIA, etc.) – and feedback will be summarized, addressed and implemented. The “official final” version is scheduled to be issued in September 2019.
Part of the various scheduled courses and conferences will also be a course on Analytical Methods for Cleaning Validation in September 2019. Further, for October 2019 it is planned to conduct a 2nd Modern Qualification Conference.
The next face-to-face meeting of the group has been scheduled for April 2019.
European GDP Association - Activities
The Code of Practice “The Responsible Person for GDP” was revised. Version 2 is now available in the members’ area of the European GDP Association website. Under the direction of Sue Mann, a small task force developed these updates to ensure this document continues to be a useful resource for those working in this sector. In particular, the changes include more information on the expectations of the role and responsibilities of a RP in line with increased regulatory agency focus on the RP. Additionally, there is further guidance on data integrity expectations and more details regarding different aspects of the role of RP where this can provide improved clarification of requirements and expectations.
The Association has started a project with PQG to create a guidance document for interpretation and implementation of the GDP requirements for APIs. Work started in November with the aim to have the new document published in November 2019. Format and structure of the document will be the same as the GDP for finished products. For this purpose a Joint Venture Agreement between the Pharmaceutical Quality Group (PQG) of the Chartered Quality Institute and the ECA Foundation was established to clarify the roles, responsibilities and accountabilities of both the PQG and ECA in the delivery of this guideline on Good Distribution Practices for APIs. Project leader is Dr Afshin Hosseiny the Chairman of the European GDP Association. The agreed intent is to make “The Guideline” available free of charge to members of ECA and PQG via the respective organisations’ websites. A professionally designed publication alike the interactive GDP Guidance on interpretation and implementation will possibly follow.
The Japanese Pharmaceutical Manufacturers Association, JPMA, asked for permission to publish a Japanese version of the “Question & Answers on Chapter 1 QUALITY MANAGEMENT of the EU Good Distribution Practice Guideline” in the periodical publications issued by JPMA. JPMA will be responsible for the accuracy of the Translation.
Visual Inspection Group - Activities
The next Board meeting has been scheduled to take place in October 2019.
An updated version of the best practice Guidance on visual inspection will be published in the 1st quarter of 2019. The updated version will comprise editorial changes and clarifications.
The group is waiting for the finalisation of the Annex 1 and will then decide whether the ECA Visual Inspection Guidance document hast to be further updated or not.
ATMP Group - Activities
Different provisions of the new European GMP guideline specific to ATMPs are discussed intensively among authorities, academia and industry involved in the development and production of ATMPs. Thus the group set up a survey to find out what the “hot topics” are for members of the ATMP Group. The survey was conducted from November through December. Results will be discussed in the Board meeting scheduled for June 2019. Planning for a new ATMP Conference in June 2019 is in progress.
IT Compliance Group - Activities
To reflect the broader scope of topics the group is covering, its name was changed to Data Integrity & IT Compliance.
The development of a Data Integrity Toolbox is planned for Q2 2019. The first documents were discussed with a few Board members.
The group (as part of the ECA Foundation) was invited by PIC/S to comment their draft of PI 041 on Data Integrity. ECA and members of the interest group will organise a workshop on 19-20 February 2019 in Berlin to comment the document.
A Data Integrity Conference as part of the Pharma Congress 2019 has been scheduled for the 9-10 April 2019 in Dusseldorf. The 12 lectures – including presentations from three inspectors – focus on manufacturing and Engineering.