01 July 2022
European QP Association Activities in the first half of 2022
What the European QP Association was working on in the first half of 2022 is summarized below.
Board meetings and resolutions
At its Board of Directors meeting in early December, the European QP Association (EQPA) decided to concretise its requirements for membership in the Association. This was due to ambiguities in the previous requirements, changes in the political landscape and planned adjustments in PIC/S countries. The changes apply to all new memberships. Existing memberships are not affected:
This membership applies for people working as a (appointed or approved) QP in a EU/EEA Member State, the UK, Switzerland or Israel.
This membership applies to people fulfilling the QP requirements according to the EU Directives and are either:
- preparing to be appointed or approved as a QP working in a EU/EEA Member State, the UK, Switzerland or Israel, but you are not (yet) registered, appointed or approved as QP
- have a similar function (Responsible Person, Authorized Person or equal) in a country that has a MRA Agreement with the EU in place, is member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) or is an official EU member candidate or proposed candidate
The EQPA Activity Plan 2022 was finalised and agreed by the board. Amongst other things it outline objectives, goals and board meetings planned in 2022.
Code of Conduct for QPs
Georg Göstl took the lead to develop a draft proposal for a Code of Conduct to QPs in the name of EQPA.
Background: Article 52 of Directive 2001/83/EC requires from member states to issue national Codes of Conducts for QPs. Alternative approaches are also possible.
According to a survey feedback, 21 years after coming into force this legal article did not result in any Code of Conduct in any current member state nor in EEA member states. All member states obviously claim to have alternative procedures developed or in place (usually without explaining to QPs which ones). EQPA wants to fill this gap.
EQPA board members were invited to comment this first draft.
Benchmarks IMP QP Working Group
For the QP Forum 2021, participants and members of the IMP Working Group had submitted a number of questions in advance via a “Call for Questions”. Many of them have already been addressed in the presentations and in the Q&A sessions. However, due to the numerous chat questions during the conference, the speakers were not able to present all the benchmarks that were prepared based on the submitted questions. Therefore, a survey was sent out. It was also asked for possible of interest for the next QP Forum’s IMP Pre-Conference.
Survey on Contract QP Activities
According to Article 48 of Directive 2001/83/EC each manufacturer has to have at his disposal at least one Qualified Person. There are no details on the contractual arrangement for this “disposal of services”, though.
As QPs in many member states offer their service as independent entrepreneurs and “contract QPs”, these states have developed rules and expectations posed on independent QPs usually without own MIA. Therefore, EQPA has sent out a survey to find out more about this area of QP activities, which is not harmonized within the EU.
Draft Act to amend Annex VI to Clinical Trial Regulation (EU)
On 01 June 2022 the Commission launched a Draft Act to amend Annex VI to Clinical Trial Regulation (EU) No 536/2014. As outlined on the Commission`s website, “this initiative eliminates the obligation to include an expiry date on the immediate packaging of unauthorised medicinal products used in clinical trials in specific circumstances (e.g. on syringes). The aim is to prevent additional safety and quality risks associated with the relabelling procedure and the need for more frequent re-supply, which may lead to delays in clinical trials.”
The IMP Working Group of the IMP Working Group has asked members for feedback to enable the group to provide a consolidated feedback from the IMP Working Group/ European QP Association.
Overall, the IMP Working Group appreciates the ongoing revision of Annex VI to Clinical Trial Regulation (EU) No 536/2014 and agrees that re-labelling procedures of immediate packaging would add significant safety and quality risks to clinical trial medication. Comments were sent to the EU Commission.
QP Forum 2022
The EQPA Board has decided to offer this year's QP Forum (01-02 December in Berlin, Germany) also as a Live Online Conference. Delegates can either attend on site in Berlin or at home/ in the office. All lectures and sessions of the main Forum will be held consecutively.
A lot of hot topics for QPs have been identified and will be discussed in the various presentations, like for example:
Preceding the Forum, two parallel Pre-Conference Sessions on specific topics will run on 30 November: Investigational Medicinal Products and Quality Culture.
- Revised EU-GMPS
- Electronics Data
- Risk Management
- Supply Chain
QP Education Course in Copenhagen
For the first after more than two years live online trainings, the QP Education Course (Module B) was held live on site again (02/03 June 2022, Copenhagen, with a pre-course session on 01 June). Altogether 30 delegates have attended (15 the Education Course and 15 both the Education Course plus the pre-course session). The overall average rating of the pre-course session on Soft Skills was 1.2; the overall average rating of the QP Education Course was 1.45 (1 = very good, 6 = bad).
EMA has opened a short 1 month public consultation today on draft set of Questions and Answers on remote batch certification by the Qualified Persons. Ulrich Kissel has created a consolidated EQPA feedback document which has also taken into account feedback received by EQPA members. Details were discussed in the course of the QP Education Course in Copenhagen. Consolidated comments were sent to EMA.
IWG meeting with Interested Parties on 10 March
EQPA and ECA were taking part at the EMA’s inspector’s Working Group Meeting with Interested Parties on 10 March (online).
The Interested Parties noted some actions during the meeting:
Comments to planned revision of the ICH Q9 Guideline
In December a draft of a planned revision of the ICH Q9 Guideline was published. The ECA Foundation together with its European QP Association set up an Expert Working Group to comment on the draft.
1. Covid-Lessons learned / GMP
2. GMP for importers (Annex 21)
EFPIA with AESGP, ECA/EQPA, EIPG, MfE, V
3. GMP for MAH
with ECA/EQPA, EIPG, MfE, PDA
4. QP Training and operations
ECA/EQPA with EFPIA, EIPG, PDA, MfE
5. EudraGMDP update and integration of OMS
6. IMP situation Ukraine
Comments and a comparison between the documents have been published on ECA’s website.
The collected comments for ICH Q9 were published by EMA on 20 April (ECA/EQPA right at the beginning).
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