Updates from the ECA Interest Groups
What the ECA Foundation's Interest Groups were working on and accomplished in the last three months of 2019 you can read in their Q4 2019 report.
European QP Association - Activities
Philippe Van der Hofstadt was winding down his IMP Working Group responsibilities after seven very successful years of excellent work. The Committee appointed Patryk Jegorow (Shire Pharmaceuticals Ireland Ltd.) to the IMP Working Group leadership team with the aim of maintaining the same spread of pharmaceutical company size representation.
In November, the IMP Working Group leadership team met in Brussels to discuss and plan the IMP Sessions for the QP Forum.
The 2019 EQPA Board Meeting was held in Munich to discuss current and future activities and first ideas for the 2020 QP Forum.
The Annex of the Good Practice Guide "Duties and Responsibilities for Qualified Persons in the EU", listing individual EU member states' requirements for becoming a QP was revised. In addition to providing the EU member states' requirements for becoming a QP, it also comprises the functional area requirements/specifics, on interest groups in the country and on its authorities. Information was amended based on a survey. The updated Guide was posted in the members' area again.
On 27-29 November, the 14th QP Forum was held in Munich at the Sofitel. With more than 300 delegates (participants plus speakers) the 2019 QP Forum set a new record. The feedback received was very good (pre-conference sessions, QP Forum, venue and overall organisation).
For the QP Forum, an App was developed to provide information about Agenda, speakers, presentations and much more. The new QP Forum App was also received very well with a lot of downloads
Two surveys were conducted: one on the QP/QPPV interface and another one on Quality by Design
The key tasks of the QPPV are maintaining the company’s pharmacovigilance system and ensuring the safety of investigational and marketed medicinal products for human use. A Qualified Person (QP) should at least understand the responsibilities of the QPPV. Both roles ideally work hand in hand to understand the remaining risks of certified batches and to mitigate risks on the market. However, legal basis and co-operation differs not only in the various EU Member States, but also within the various companies. To get a better picture and an overview, the EQPA has set up a survey on the QP – QPPV interface. Results will be provided in the members’ area on the website.
Few hard facts are known about the pharmaceutical professionals’ opinion and the pharmaceutical companies’ approaches on Quality by Design in the European Union. A survey designed by Maria Papantoniou, postgraduate at De Montfort University in Leicester, UK, aims to help in assessing perceived positives and negatives, as well as the level of implementation of Quality by Design in the EU. Maria summarised the results in an article which was published in EQPA Membership Letter – also available in the Downloads section of the members’ area.
With the support of EQPA, the “interested parties” (AESGP (Association of the European Self-Medication Industry), AnimalhealthEurope, APIC (Active Pharmaceutical Ingredients Committee), EAEPC (European Association of Euro Pharmaceutical Companies), EBE (European Biopharmaceuticals Enterprises), EFPIA (European Federation of Pharmaceutical Industries and Associations), EIPG (European Industrial Pharmacists Group), EQPA (European QP Association), GIRP (European Healthcare Distribution Association), ISPE (International Society for Pharmaceutical Engineering), Medicines for Europe, PDA (Parenteral Drug Association), VE (Vaccines Europe) have sent a letter to Brendan Cuddy, Head of the Manufacturing Quality and Supply Chain Integrity Service at EMA to bring some priority topics to the attention of the GMP/GDP IWG. The interested parties are asking for consideration and feedback on these priority topics via a meeting or webinar:
- GMP for sterile products (EU-GMP Annex 1)*
- Drug Shortage Prevention
- Changes to the EUDRA LEX Vol 4 (EU-GMPs)
- Implementation of the MRA EU/US*
- Inspections in the framework of FMD (Directive EU 2011/62)*
- QP Responsibilities*
*supported by EQPA
In the response letter sent out on 9 December, EMA agreed to set-up a web-based meeting for 2 hours on January 23rd, 2020. Dr Ulrich Kissel, Chairman of the EQPA, agreed to join on behalf of the European QP Association and ECA.
EQPA was invited by the Brazilian Association of Pharmaceutical Ingredients Industry – Abiquifi to discuss recent changes in the Brazilian API regulations in Sao Paulo. David Cockburn attended the seminar which was conducted in 2 parts. The first part was in Portuguese and ANVISA was well represented explaining the new legislative proposals and reacting to various points that came out from the public consultations. The 2nd part was in English with David, a consultant from China and a representative from APIC/CEFIC speaking.
The EQPA website has been completely revised and reorganised. Services remained the same, however the site now provides a better overview and a more modern design.
Pharmaceutical Microbiology Working Group - Activities
To take into account the changes in the field of microbiology and microbiological QC – especially the increasing importance of contract laboratories – two new Board members were appointed: Dr Johannes Reich, Microcoat Biotechnologie, and Dr Thomas Meindl, Labor LS. Dr Micha Nübling has assumed a new position at the Paul-Ehrlich-Institute (German Federal Institute for Vaccines and Biomedicines) and thus resigned from the Board.
The Board met in November. One of the topics there was the new Chapter 2 of the Group’s OOS/OOL Guideline Dealing with Deviations in Endotoxin Testing. The authors are implementing the changes from the review of the Board, creating the final document. Chapter 2 is supposed to be presented at the European Microbiology Conference in May 2020.
Analytical Quality Control Group - Activities
Validation Group - Activites
The second public draft version of the ECA Draft Good Practice Guide Modern Qualification was launched at the Launch Conference in October. The document is available in ECA Validation Group website members’ area free of charge. During the conference, there were very open discussions for a further development of the public draft version 2 to a final version. Comments were possible until end of 2019. For the further development a first face-to-face meeting was scheduled for end of January 2020 with further telcons following. It was also planned to add two more sub-groups – which are supposed to concentrate on documentation and on single-use systems.
European GDP Association - Activities
As of January 2020 Dr Markus Funk will be replacing Wolfgang Schmitt as Administration Manager.
The next Board meeting was scheduled for end of June in Barcelona – around the Group’s planned GDP Forum, members were invited.
The project with PQG to create a guidance document for the interpretation and implementation of the GDP requirements for APIs was well on track. The combined draft document is in final review.
The Association’s website has been completely revised and reorganised. Services remained the same, however the site now provides a better overview and a more modern design.
Visual Inspection Group - Activities
The latest version of the Best Practice Guidance on Visual Inspection was published in October – and was handed out during the Visual Inspection event in Vienna in October.
During the board meeting following the event it was decided to further adopt the paper with topics comprised in the new Annex 1 draft. This was scheduled for the beginning of 2020. Minor adoptions necessary were planned to be taken are of following the meeting.
Dr Tobias Posset announced that the Group’s paper has not been referenced in the new EP monograph (5.17.2 RECOMMENDATIONS ON PARTICULATE CONTAMINATION: VISIBLE PARTICLES). To accomplish that it has to be officially published within a common paper first. It was therefore decided to publish the paper after its revision in (for example) the Pharm. Ind. Journal.
It was further decided to adopt the Position Paper on CCIT, currently available in version 1.1. The major part was written by Dr Tobias Posset, the Group’s Chairman – and a final version was circulated for a final review.
The next annual meeting – the Control of Parenterals Conference with CCIT & Visual Inspections Systems pre-conferences was scheduled for November 2020.
The Group further decided to take advantage of the possibility to conduct surveys among the ECA Visual Inspection Group members to find out more about the industry’s opinion regarding specific topics. AQL limits used, criticality definitions for particles used were identified as possible topics. It was agreed to send out a proposal for a survey to the group before the next ECA conference – to present this during the conference.
ATMP Group - Activities
The Group was invited to comment on the new PIC/S Annex 2 draft. Comments were collected via a survey to the members as well as in an ATMP session within the PharmaLab Congress mid of November.
The date for the Board Meeting and the ATMP Conference 2020 was set mid June 2020. Continuing the close coordination with the European QP Association, Christoph Peter and Anette Jork (BioNTech) and Christoph Prinz (Apceth) were invited as guests. They are also planned to present at the conference.
IT Compliance Group - Activities
As Karl-Heinz Menges retired from the Group’s Board, Franz Schönfeld was invited to follow him.
The new Guide “DI in clinical trails” as part of the ECA DI Guide was still in the development phase.
The Group was invited to comment on the new WHO DI Guide. Deadline for the comments was scheduled by WHO for the end of January.