Updates from the ECA Interest Groups
To find out more about the ECA’s Interest and Working Groups accomplishments and current activities in the third quarter 2017 please read following their report.
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
- First reviews of the draft guidance document on deviation handling in non sterile manufacturing were received and reviewed.
- The Annual Board Meeting has been scheduled on 6 November in Neuss, Germany.
- A Microbiology Newsletter was published in September.
- An article focusing on Cleaning and Disinfection Requirements was published in the trade magazine Cleanroom Technology.
Analytical QC Group – Activities
- The 2nd AQCG Board Meeting was scheduled for 11 October, where the following main topics will be discussed:
- Further development of the Guideline for "Analytical Procedure Life Cycle".
- Launch of the Workshop Conference on 23rd & 24th November in Vienna.
- Update of the ECA AQCG website to be launched in Q4.
Validation Group - Activities
- The new ECA Qualification and Validation Task Force met again in Frankfurt, where a first internal draft of ECA`s Good Practice Guide "Modern Qualification for fast track qualifications" was discussed. At the end of October section 4 "Quali-fication phases in a timeline" with a high-level model should be drafted by suppliers of the group. The next meeting is planned for 6th November again in Frankfurt.
- A week for a modern ECA Qualification Conference 2018 has been fixed. At this Conference the Good Practice Guide "Modern Qualification" is supposed to be published as official draft.
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 group meeting has been scheduled to take place from 10-12 October 2017 in Vienna.
- The group’s chairman Tobias Posset is now official member of EDQM’s Expert Group 12 (Dosage Forms & Methods). Expert Group 12 is responsible for developing the chapters of the European Pharmacopeia on Visual Inspection and Container-/Closure Integrity testing of parenterals.
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.