ECA Foundation Board Annual Meeting Report

Recommendation

Monday, 29 April 2024 10.00 - 16.00 h

Introduction to the AQCG’s new ECA Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation
Includes USP Speaker Update on the Analytical Procedure Lifecycle

Every year the ECA Foundation Advisory Board conducts its annnual meeting to review past and determine future activities. This year the meeting was held in Heidelberg, Germany, following the very successful 4th European GMP Conference.

During this year's meeting the board mainly focused on two topics: on already established and potentially new working groups and the Foundation structure itself.

Today, the ECA Foundation is the leading European membership organisation with regard to pharmaceutical Quality Assurance and GMP compliance, counting close to 4.000 members from more than 60 countries around the globe. The very positive development is also shown by the increasing attention from both industry and authorities and is in large parts also due to the various working groups, as they are the core of ECA's activities.

Developments in the established Working Groups

The first interest group established within the ECA was the European QP Association. By now this group unites close to 1.500 Qualified Persons and aspiring QPs as well authority representatives from almost 40 countries. To further develop its relationship with authorities, the group established a new membership opportunity: the liaison membership which is exclusively reserved for representatives from regulatory authorities, inspectorates or industry associations, institutions or organisations.

The group provides QPs with a platform for exchaging information and experience and for discussing current and learning about future challenges. In addition to the continuous attention the association receives from colleagues in the industry, authorities increasingly appreciate its input which is frequently based on the comprehensive feedback to surveys conducted among its members. This is also the reason why the QP Association has been invited on a regular basis to the EMA GMDP IWP Interest Parties Meetings and is also invited to discuss the revision of Annex 16.

Besides supporting European QPs by acting as the "QPs' voice", the association also provides services like the shared audit database, allowing them to find potential partners and contact them for sharing audits of suppliers and services. Moreover, to get more colleagues actively involved in external activities, the association just recently decided to form an Expert Panel. This Expert Panel will be involved in the work of the Advisory Board, e.g. in the preparation of comments to the EU Commission on new guidelines, participating in meetings with authorities, writing Good Practice Documents etc. For that purpose the group is interested in colleagues who already reached a certain level of seniority in responsible positions within a pharmaceutical company or in a comparable venture (to learn more, please send a note to admin@qp-association.eu).

In the same year the ECA founded the Rapid Microbiological Methods (RMM) Group with the goal to support a clear forward path for using RMMs for new submissions and to help both authorities and industry get a better understanding of the requirements for the introduction of RMMs and to provide them with guidance based on case studies and available experience. Today, this group already counts more than 300 members from 41 countries.

To support its goals the group developed a database for available Rapid Microbiological Methods, by now comprising close to 30 different systems. Its also conducts surveys, providing authorities and organisations with valuable information on the use and the challenges of RMMs. The group is also continuously developing topics for new courses and conferences. To get group members more actively involved it also plans on conducting a survey with the goal to get a more detailed view on the interests, systems in use etc and to schedule further activities like subgroups, pre- or post conference workshops.

In fall 2010 the ECA founded its third interest group - the Analytical Quality Control Working Group. This group aims at addressing professionals - including technical staff and management - involved in routine Quality Control & R&D testing laboratories for APIs, excipients, drug products as well as in herbals and and plans on covering topics like Quality Management Systems and Laboratory Compliance, Sampling and Sample Management, Qualification and Validation of Laboratory Instruments and Systems, Data Quality Management and special topics like impurities, dissolution testing and others. The group was established with an entire set of goals and objectives:

• Provide an European wide networking platform for Analytical Chemist and Scientists working in or managing a Quality Control environment.
• Promote active discussion of the latest regulatory standards for Quality Control within the European Union and US.
• Identify and address technical issues and challenges within the Quality Control environment including training needs.
• Actively support a harmonised approach to common problems and issues by generating of discussion/position papers and generic procedures via expert working groups.
• Facilitate an effective and efficient communication between industry, competent authorities and the pharmacopoeias.

With its first project, the group wants to generate a harmonised SOP on managing analytical deviations within the laboratory including OOS, OOE and OOT results. The projetc's overall goal is to promote a harmonised, generally accepted approach within the EU by publishing of a final document on the ECA website. A first call for ECA members and members of the European QP Association to get actively involved, was very successful: 140 people registered as OOS Review Team Members to provide their feedback, and approx. 80 members forwarded detailed feedback and comments and proposals for alternative flowcharts.

Potential for new Working Groups

New developments and guidelines provide plenty of opportunities for new working groups. "We are always looking for new guidelines," said Richard M. Bonner, Vice Chairman of the Board. "For instance, we are looking at counterfeiting. The supply chain is also a big area - being able to maintain the integrity of the supply chain is a big issue. There is a new directive coming which will require the QP to sign off on the integrity of the supply chain. There are lots of areas we are going to look at in the future."

ECA Foundation Structure

As the working groups are the core of ECA's activities and to ensure that these groups are also represented appropriately in the Foundation Board it decided to extend the Board. For that reason the chairs of the various interest groups will be invited to join the Board. This extended Board will then form the "Executive Committee."

New ECA Foundation Board Member

As the long-term Board Member John Taylor from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) had to step down from the board for professional reasons, his colleague Ian Thrussel took his place and participated in the meeting for the first time.