Updates from the ECA Interest Groups
Following you can read about the activities of the ECA Foundation's Interest Groups in Q3 2020.
European QP Association (EQPA)
To revise the European QP Association’s Good Practice Guide Ulrich Kissel sent out an updated and revised draft for comments. The final version is planned to be available for publication in November.
The results of the survey on Remote QP Certification were published in the members’ area of the EQPA Website and in the EQPA Membership Letter.
The European QP Association’s IMP-Working Group has set up a survey on “Compassionate Use / Managed Access Release Requirements” to help getting an overview of the various regulatory requirements and concepts.
Background: Non-approved medicines can be made available to patients suffering from life-threatening or serious medical conditions where no satisfactory treatment option exists.
Numerous concepts exist that can apply to individual patients or groups of patients. These concepts relate to products that are typically in Clinical Development and/or a Market Authorization Application is ongoing. Such concepts are named e.g. compassionate use, named patient use, expanded access, managed access, pre-approval access, post-trial access, and others.
The EQPA has sent the team’s consolidated final version of comments to the Annex 21 draft to the EU Commission (also available in the members’ area) – comprising numerous significant comments. EQPA highly recommends a 2nd draft, the current one has significant shortcomings, which to EQPA’s assessment can not be closed in one next step.
IWG/Interested parties meeting with EMA: EFPIA is taking the lead to co-ordinate the IWG/Interested parties meeting with EMA. ECA/EQPA are invited to prepare a letter to trigger discussion with EMA-IWG. It is expected that EMA-IWG will make themselves available in a teleconference as in the last years. This would be the third year in a row, where no face to face meeting at EMA will be organised. Due to limited resources at EMA telecons were organised during the first months of the new year and not in November as before.
The latest edition of the EQPA Newsletter is now also available in the download section of the members’ area.
Pharmaceutical Microbiology Group
After the Group had issued the first chapter of its Guideline Evaluation and Investigation of Microbiological Deviations in the second quarter of 2018 already, the second chapter entitled “Lab Investigations – Endotoxin Out of Specification (OOS)/ Out of Trend (OOT)/ Atypical Results Investigations” was completed and issued in quarter III of 2020. Further, the third chapter was completed as well and is currently in review.
The Group also revised its website, which was launched recently. Updates of literature and guideline lists are also in progress and underway.
The Validation Group’s Task Force developed ECA´s Integrated Qualification and Validation Draft Guide to a final version. It implemented feedback from the 2019’s Launch Conference. The final version is thus a comprehensive revision, also comprising new chapters about process validation and equipment qualification as well as a new chapter on electronic qualification. Participants of the Launch Conference end of October 2020 receive a copy of the final version.
A face-to-face meeting of the above mentioned task force was planned before the Launch Conference on 26 October 2020. Due to Covid-19 this meeting will be organized online. Due to this pandemic courses/conferences are also already and – for the time being – will continue to be conducted online.
A survey about electronic documentation in qualification projects was published in the GMP-News.
European GDP Association
Emil Schwan was invited to join the Advisory Board and accepted his nomination. From 2017 until May 2020 he was a member of the GDP Association Authority Advisory Board. After eight years working for the Swedish Medical Products Agency (MPA), he decided to leave the agency. He is now working as a Senior Consultant for RegSmart Life Science AB.
The next board meeting will take place in June 2021.
The final document “GDP for active substances guidance on interpretation and implementation” has been published in June 2020. Since August 2020, the interactive PDF version is accessible free of charge in the member's area of the European GDP Association website. The GDPA website was updated accordingly.
A GMP and GDP Conference is scheduled to take place in June 2021. The second day will be a “joint day” – the GMDP Forum. A draft version of the agenda was created. First speakers were already invited.
Markus Funk wrote an article about GDP for APIs for the GMP Journal. This article refers to the "GDP for active substances guidance on interpretation and implementation”.
Prabjeet Dulai represented the ECA and the European GDP Association at the 5th Annual International GDP Conference in Serbia 2020. Originally the conference was planned for April 2020 but due to Covid-19 it was postponed and took place in September. The title of her presentation was “The Power of Building Relationships - the role of the European GDP Association".
Visual Inspection Group
The Visual Inspection Group’s Position Paper on CCIT was published as version 2.0 already in March 2020. Further, the new version 3.2 of the ECA Guidance on Visual Inspection 3.2 was published on the group’s webpage in May 2020.
Due to the corona crisis, but considering the importance of face-to-face meetings, it has been decided to postpone the Group’s meeting to 2021. It will now take place in November in Berlin, Germany.
To fulfil the demand of training, however, a short-term course covering the fundamentals of visual inspection will take place online in December 2020.
The ECA Visual Inspection Group provided their feedback to the new Annex 1 Draft to the ECA Annex 1 Task Force.
Due to the pandemic the annual conference on Quality, Safety and GMP Requirements for ATMP could not take place in June and had to be postponed to November as an online event.
PIC/S contacted the ECA again for their stakeholder consultation regarding Annex 2A Manufacture of Advanced Therapy Medicinal Products (ATMP) for Human Use. The consultation was passed on to members of the board for comments, and comments were submitted via the ECA.
Moreover, EFPIA asked the Group for their input on the Position Paper on the Topic of ICH Guidance on Development and Manufacture of ATMPs – which was also submitted via the ECA’s Co-Chair, Lance Smallshaw.