European QP Association Activities in the first half of 2021
What the European QP Association was working on in the first half of 20221 is summarized below.
IWG/Interested parties meeting with EMA
EQPA was invited by EMA’s GMDP IWG for a teleconference with other stakeholders on Friday 22nd January. For preparation of the meeting, EFPIA invited for a coordination call to discuss. Main topics were the EMA GMP/GDP -IWG Working plan 2021, covering progress on new/updated guidelines and inspection and audit management in a changing environment.
IMP Working Group The IMP Working Group has commented WHO’s Working Documents QAS/20.863 “Good manufacturing practices for investigational products” and QAS/20.865. Documents were submitted to WHO.
IMP Working Group has prepared and published a regulatory requirement summary on Compassionate Use/ Managed Access for QPs. The Summary contains the requirements on 40 different Compassionate Use/ Managed Access types from 28 countries of the EU/ EEA and the UK.
Surveys
After one year under the measures to cope with the COVID-19 pandemic EQPA asked for an update on the overview of different national requirements/ expectations from the QP regarding presence on site and remote certification. A survey on this was already sent out about one year ago. But a lot has happened since the early days of the pandemic and procedures and approaches have been adjusted by Health Authority communications as well as internally in organizations and work places. With this survey EQPA wanted to learn more about changes to these expectations in the view of inspectors as well as the members’ view and perception. Results have been summerised and were published on the website and in the EQPA Membership Letter.
Survey on Directive 2001/83/EC articles 48 till 52: Directive 2001/83/EC forms and defines the legal framework of the role of the QP in the five articles 48 till 52. Discussions often focus on article 49 defining the minimum requirements to become a QP. Less attention is often given to the provisions set by article 52. EQPA wanted to get an overview of the different national solutions and approaches for article 52 compliance, QPs’ experiences and assessment. The survey therefore specifically focused on the way and mechanisms how article 52 and the code of conduct or equivalent are being implemented and enforced in the member states.
QP Forum
The decision was made to offer this year's QP Forum also as a Live Online Conference. All lectures and sessions of the main Forum will be held consecutively and can be attended by all participants - either directly on site in Berlin or live online.
A first programme with three pre-conference sessions was finalised and published.
Miscellaneous
The two discussion forums on the EQPA website (IMP and the regular one) were combined. The IMP discussion forum remains as a “read only” forum on the website for a while. With this, members can still have a look at older entries.
David Cockburn and Ulrich Kissel worked on an article on Remote Certification to be published Euromed’s magazine Industrial Pharmacy.
Job Description:
Under the leadership of Georg Göstl, EQPA developed and published a Job Description Template for QPs.
David Cockburn has written an article for Euromed Publications GMP Review: Good Manufacturing Practice and the Marketing Authorisation Holder (When does a marketing authorisation holder have to comply with GMP?) The article will also be published in the EQPA Membership Letter.
