Updates from the ECA Interest Groups

Find out more about the activities of the ECA Foundation's Interest Groups in the last quarter of 2020.

European QP Association (EQPA)

In the Board Meeting, this time conducted online via WebEx in December, current and new activities were discussed. First ideas for QP Forum 2021 were collected and discussed.

The Good Practice Guide so far known as “Duties and Responsibilities for QPs in the EU” has undergone a major revision and was published with the new title “Code of Practice for QPs – Duties and Responsibilities for Qualified Persons in the EU” – including an update of Annex 1 with the EU member states’ national requirements for becoming a Qualified Person and with other national specifics.

The WHO issued new working documents on IMPs and research and development facilities for public consultation. Planning to provide the WHO with comprehensive comments for these new documents the IMP working group therefore invited working group members to give comments.

The QP Association’s chairman, Dr Ulrich Kissel, attended teleconferences on proposals for topics to be discussed by the interested parties with EMA-IWG during a proposed EMA-IWWG interested parties meeting. During the first teleconference in October, all interested parties shared their list of proposed topics, which were now defined. The process itself starts with drafting and finalisation of a letter addressing the need for clarification or action. Interested parties volunteer to draft the respective paragraphs of this letter on identified topics coordinating with e-mail input of the other defined interested parties. In three topics the ECA-EQPA was supposed to take the lead in preparing and aligning with other associations the associated problem statements expressed to EMA-IWG: The letter itself has caused some discussions between the interested parties. However, most concerns from EQPA have been considered.

The EQPA is invited by EMA’s GMDP IWG for a teleconference with other stakeholders end of January. Main topics to be discussed include the EMA GMP/GDP -IWG Working plan 2021; covering progress on new/updated guidelines such as Inspection and Audit Management in a changing environment as well as further topics of concern. For preparation of the meeting, EFPIA invited for a coordination call to discuss the next steps in January.

The EQPA was further invited by EMA to join a webinar on the “UK withdrawal from the European Union – End of Transition period” end of November. EQPA’s questions have been taken up at the end and prioritized against others, however many other questions were left unanswered.

This year's QP Forum on end of November was only available as a Live Online Conference. As all lectures in the main Forum and the Pre-Conference Sessions were held consecutively, delegates could follow them right on their screen. Two parallel Pre-Conference Sessions were preceding the Forum: Serialisation and Investigational Medicinal Products. The online version of the Forum was very successful. Overall, 230 delegates joined over the four days, evaluating the Forum very positively.

www.qp-association.eu

Pharmaceutical Microbiology Group

Due to the corona pandemic the Board Meeting was postponed to 2021.

In terms of guidelines the group completed the review of the third chapter and passed it on for approval by the Chair/Vice Chair. Its publication is supposed to be in 2021 – possibly at the European Microbiology Conference.

The group further reviewed the literature guideline and paper lists on the website, which is still in progress

www.pharmaceutical-microbiology.org

Validation Group

A Task Force developed the final version of the Integrated Qualification and Validation 2nd Draft Guide. It is a deep revision also with new chapters on process validation and equipment qualification as well as a new chapter on electronic qualification. The final version was published at the online Launch Conference end of October and is now available on the Group website.

An online meeting of the above mentioned task force took place on end of October. The members agreed on working on a version 2.0 for 2021, in which feedback from the launch conference will be implemented. The development will mainly be coordinated via telecons. New subgroups will handle the topics contracting, remote-FAT/SAT, single use equipment and regulatory endorsement.

www.validation-group.org

European GDP Association

The next board meeting is scheduled for June 2021.

The group developed a GMP and GDP Conference, the “European GMP & GDP Forum”, scheduled to take place on 22, 23 and 24 June 2021. Day 1 will concentrate on the GMP Part, Day 2 will cover both GMP & GDP, and Day 3 is reserved for the GDP Part. The programme was finalized and published.

During the Q&A sessions of different GDP Live Online Training Courses, interesting questions were collected to be summarized and used to create/expand new Q&A documents to be published on the GDPA website. It is planned to start answering and publish the questions within Q1/2021.

www.good-dsitribution-practice-group.org

Data Integrity & IT Compliance Group

The integration of GDP aspects regarding DI was finished in Q 4. The final DI Guide V3 is supposed to be published in 2021.

A new ECA DI course on DI Audits & Inspections was established.

www.it-compliance-group.org.