Updates from the ECA Interest Groups
Every quarter the ECA’s Interest and Working Groups inform about their accomplishments and current activities. Please read following their report for the second quarter 2017.
European QP Association - Activities
- New record of the number of group members in Q2/2017: more than 2.500 in total.
- Survey: What is the current practice of Manufacturing Authorisation Holders’ oversight of CMOs for batch release? This survey was intended to benchmark the practices across a number of pharmaceutical companies in relation to oversight of batches manufactured by Contract Manufacturing Organisations (CMO's) on behalf of Marketing Authorization Holders (MAH) - and specifically for those working within an organisation (MAH) that subcontracts manufacture and/or release of batches. The results of this survey will be published as part of a Thesis for a Masters in Industrial Pharmaceutical Science.
- The ECA is currently establishing a dedicated ATMP working group. The ATMP Task Force of the IMP Working Group supports this Group within ECA.
- Matthew Scherer, Assistant Health Attaché and International Program and Policy Analyst, FDA Office of International Programs - Europe Office, has accepted an invitation to speak at the QP Forum in December and will present current and future activities of the FDA.
Pharmaceutical Microbiology Working Group - Activities
- In the second Quarter 2017 17 new members joined the group, raising membership to close to 530.
- The guidance document for deviation handling in non sterile manufacturing is ready for being shared with the members.
- A new course on Bioburden testing was finalized.
- The date for the European Microbiology Conference 2018 has been fixed: it will be conducted from 24-26 April 2018 and include a Data Integrity Workshop.
- The Pharmacopoieal Update Session at PharmaLab has been fixed with two USP Experts, one EDQM Expert and two Industrial Members of the USP Expert Groups and the Swiss Representative of the EP Microbiology Expert Group as Moderator.
Analytical QC Group – Activities
- The Group currently counts more than 130 members.
- An AQCG Board Meeting was held to discuss the next steps of the group.
- The Board agreed on a draft agenda and have identified speakers.
- A workplan for the ECA Draft Guideline was outlined.
- The APLM (Analytical Procedures Lifecycle Management) Workshop is going to take place from 23 – 24 November 2017 in Vienna, Austria. There the ECA APLM (Analytical Procedures Lifecycle Management) draft guideline will be launched, providing the opportunity to gather industry input and comments for the ICH Q2 revision process as well as to discuss USP activities on General Chapter <1220> and the ECA APLM Draft guideline in a workshop environment.
Validation Group - Activities
- The number of group members rose to 728 in total.
- Successful Validation session at 7th GMP Conference, 30 May/1 June 2017, Prague, rated with 2.0 (1: excellent, 6: fails).
- Meeting for the new ECA Qualification and Validation Task Force. Six sections were identified which should be handled in an ECA “Modern Qualification guide for fast track qualifications”. The goal is to have a draft in June 2018. First tasks were identified.
- A date for a modern ECA Qualification Conference was identified.
European GDP Association – Activities
- New record of the number of group members end of Q2 2017: close to 1.300.
- The group started planning the 2018 GDP Conference.So far ten speakers have accepted an invitation to present at this conference.
- Progress on the GDP document: Final editing of the document and compilation into one single document was completed. Final draft was sent for final review. Launch supposed to be in Q3/Q4.
- Contact was established with KCL (Korea Conformity Laboratories). They are leading a project to create packaging standards, funded by the South Korean government for four years. The scope is packaging of medical devices, biopharmaceuticals and food to foster (temperature) controlled transport and monitoring. Besides a lack of standards (for South East Asia), they also see a lack of education in this area. The GDP Association will possibly support them with speakers for a potential conference on this topic in Seoul and may also support a training course together with them. This course should be held in Seoul and also attract delegates from other Asian countries.
Visual Inspection Group - Activities
- The FDA officially commited to speak at the ECA Visual Inspection Meeting in October.
- The work on the position paper concerning CCIT was finalised. Information was sent to all members of the ECA Visual Inspection Group. The paper is available in the download section of the group’s webpage.
- The group’s chairman Tobias Posset has established contact with the German BfArM for the EP chapters on visual inspection.
IT Compliance Group – Activities
- By now there are 300 members in the Group.
- The IT Compliance Group collaborates with the AQC Group for version 2 of the Data Integrity Guide. It is supposed to be issued in Q4 2017.
- The group is currently evaluating the subject IT security and potential documents on this subject.