ECA's 13th Annual Review (2011)
Annual Review 2011
ECA Membership Development
In the year 2011 memberships gained through participation slightly declined. By the end of the year the organisation had close to 2.500 members from more than 50 countries.
Moreover, the ECA also counted 40 individual and 10 company Memberships.
In addition, the organisation counted close to 50 members via the one year individual membership and close to 10 company membership from companies throughout Europe and beyond.
ECA Interest Groups further expand
As in the years before the European QP Association also expanded throughout 2011 – up to more than 1.500 members and over 160 associate members.
In the summer the Association conducted a conference in Bethesda, Maryland, USA, for the first time. It was designed by QPs and international experts as a forum with a focus on sharing information and experience and on discussing the critical areas of European GMPs and the QP’s daily work. Speakers from FDA, EMA and the European QP Association presented latest developments, current issues and shared their point of view. During two post-conference sessions covering batch release and investigational medicinal products, various case studies were presented and discussed to come up with possible solutions.
The Conference attracted delegates from all over the U.S. who wanted get familiar with the latest development regarding European GMPs and the duties and responsibilities of the Qualified Persons according to the European regulations.
To give the huge amount of information a better structure and to arrange its website more clearly, the European QP Association also gave its internet platform a new look and feel.
Already in spring the Association had decided to develop a new structure and to integrate more colleagues into its Board activities to cope with the increasing requirements to comment new European legislation or to proactively influence regulatory activities influencing the QP’s role and responsibilities. Following, in fall, some colleagues volunteered to become members of a new Expert Panel, intended to be involved in the daily work of the Advisory Board, like preparing comments to the EU Commission on new guidelines, participating in meetings with authorities, writing Good Practice Documents etc.
ECA’s second Interest Group, the Rapid Microbiology Method (RMM) Group also slightly grew. By the end of the year it counted more than 320 members.
Throughout the year the group added further systems to its RMM database, expanding it to close to 40 systems listed in the database and providing unique possibility to get an overview about available systems and their possibilities. The database exclusively available in the members area gives members the chance to compare any systems under the aspects of detection range, analysing method, detectable organisms and several more criteria.
The annual meeting of the RMM Advisory Board was hosted by Roche Diagnostics in Penzberg, Germany, where the group discussed issues like a RMM abbreviations glossary, pre- or post-conference workshops to establish smaller discussion groups in the conferences, the compilation of a list of the "most frequent failures" during implementation of RMMs as well as ways to get group members involved more actively.
In 2011 ECA’s new Analytical Quality Control Group started its first project, the generation of a harmonised SOP on managing analytical deviations within the laboratory including OOS, OOE, and OOT results. In February all OOS Review Team members received the Draft Annotated OOS flow chart. Feedback to this flow chart was much more than expected – the OOS Review Team received more than 80 responses and comments. A second review cycle was conducted later the year, and the final OOS SOP is supposed to be published soon.
As Process Validation is drastically changing in the US and in the EU – from the magic three batches to a more process knowledge and understanding concept based on scientific sound principles – the ECA Foundation also decided to set up another Interest Group in June 2011: the Process Validation Group. This group also wants to establish a European wide networking platform for facilitating active discussions of the latest regulatory requirements and to identify and address technical issues and challenges. Discussion/position papers and generic procedures are further supposed to provide an active support for a harmonised approach to common problems and issues.
During the year the ECA also conducted a number of surveys. For instance, since Chapter 5 "Production" and Chapter 7 „Outsourced Activities“ of the EU GMP Guide were revised and published on the European Commission's GMP information page the ECA wanted to find out industry’s opinion about the impact of the regulation. The result – close to 160 colleagues responded – was impressive and was thus sent to the EMA.
To support its new Interest Group and to find out what professionals in the industry think about EMA´s new approach to process validation the ECA also conducted a survey focusing on the planned changes. The survey yielded some surprises. Surprising was, for instance, the noticeable high number of participants (and also the number of comments). 509 persons providing input truly showed that validation is a topic that bothers the industry. Results were also forwarded to EMA.
Version 13.0 of the Guideline Manager Software
In 2011 version 13 of the well known GMP Guideline Manager Software became available. It is one of the most attractive benefits for ECA Members and is an exclusive and free of charge service for individual and company members. Individual members receive the single user CD, company members a multi-user version for installation on the company server. The fee for individual membership is 190,- EUR, the fee for company members depends on the number of employees
European Compliance Academy (ECA) becomes Lufthansa Mobility Partner
After Lufthansa already offered special discounts for attendees of selected ECA courses and conferences, ECA became Lufthansa mobility partner.