ECA's 11th Annual Review (2009)

Annual Review 2009

ECA Membership Development
In 2009 the ECA celebrated its 10th Anniversary. Throughout these 10 years the organisation showed a steady membership growth. End of 2009 it counted close to 3.400 members from 60 countries by participating in an ECA course or conference.

In the second year after initiation of the two membership opportunities individual and company membership, professionals also increasingly perceive these types of affiliation as very beneficial. More detailed information on these membership opportunities can be found here.

Members' Survey In 2008, the ECA conducted a survey with the purpose to find out members' perception of the organisation and to better meet the needs and expectations of professionals in the biotech and pharmaceutical manufacturing industry. The results provided some good indications for how members really perceive the ECA and its information and advanced training services and where it is necessary to put an emphasis on. A number of actions were derived already - among others the establishment of new interest groups as well as an enhanced professional development programme for GMP professionals. In addition, the organisation also seeks a closer contact to regulatory agencies to provide feedback from its members.

Membership Growth also in ECA Interest Groups The Rapid Microbiology Method (RMM) Group, established in 2006, today has nearly 200 members from Europe and abroad. In 2008, Dr Sven Deutschmann, Director of the Microbiology QC Department at Roche Diagnostics, was appointed as Chairman of this Working Group. Under his leadership the group plans on establishing an annual meeting similar to the European QP Association's QP Forum. In addition current activities are under development to provide a more practical help for its members in the enhanced member section. More information on this interest group is available here.

Today, the European Qualified Person Association already represents more than 1.000 QPs, and it still receives a lot of new membership applications. One of the success factors of the group is the fact, that it provides a strong common voice for the needs and concerns of QPs throughout Europe. Surveys among the members are used to give the regulatory agencies a clear picture of the current situation with regard to compliance issues and the success as well as the problems caused by new regulations. The Association has developed a Good Practice Guide which aims at supporting QPs in interpreting the legislation. The Guide also summarises the different legal situations in all member states. The harmonisation of these national requirements is a main objective of the European QP Association. Find out more about the European QP Association.

Publications FDA Warning Letters Report 2008 Issued Almost a traditional report already, the analysis of the FDA Warning Letters - the CD "FDA Navigator" with handbook - was issued just recently. It contains the most important GMP regulations, guidelines and interpretations by the US authority, warning letters on GMP deviations of the last three years, warning Letters Report with detailed analysis, an inspection checklist based on the cGMP Guide and a lot more. A comfortable search function allows to search all documents on the FDA Navigator CD by keywords. More information is provided on the website in the publications section.

New Release 11.0 of CD-ROM "GMP Guideline Manager" Just as much a tradition and very unique and useful is the GMP Guideline Manager CD. Like in the years before, this version contains plenty of guidelines from all important authorities worldwide, comprising several thousand pages of regulations. It also holds the FDA Warning Letters from the past three fiscal years. Through a comfortable search function users can browse the complete CD content by key words and directly retrieve guidelines and regulations they are specifically interested in.

The free of charge CD-ROM is an exclusive service for ECA event attendees and members.

GMP Matrix GMP tools like the GMP Matrix (Good Practice Guide) aim at establishing a relationship between the US-American cGMP rules for drug products and the EU/PICS GMP guide - facilitating a better overview and understanding of GMP requirements defined by various regulatory authorities. To make the matrix complete, it also includes DIN ISO 9001:2000 requirements. As the ISO basically defines specifications for a universal quality system across industries rather than concentrating on product and process quality, it is intended as an additional reference only, describing complementary requirements.

GMP Certification Programme ECA currently offers the following qualification levels:

  • ECA Certified Validation Manager
  • ECA Certified Quality Assurance Manager - Pharmaceutical Production -
  • ECA Certified Quality Assurance Manager - API Production -
  • ECA Certified Quality Control Manager
  • ECA Certified Pharmaceutical Engineering Manager
  • ECA Certified Computer Validation Manager
  • ECA Certified Regulatory Affairs Manager

As in the previous years the ECA will further develop the programme to offer new certifications and keep the program concurrent.

Advisory Board Members The ECA is based on voluntary work of its members and Advisory Board members. This will not change in 2009. The Advisory Board Members are:

Active pharmaceutical ingredients Matt Moran, IPCMF, Ireland
Computer validation (incl. Part 11) Dr W. Schumacher, F. Hoffmann-La Roche, Switzerland
GMP supervision

Rudolf Völler, Regierungspräsidium Darmstadt, Germany John Taylor, MHRA, United Kingdom

Analytical quality control Dr Ludwig Huber, Germany Dr Bernd Renger, Vetter Pharma-Fertigung GmbH, Germany
Microbiological quality control Colin Booth, Oxoid Ltd, United Kingdom
Quality Assurance Richard Bonner, formerly with Eli Lilly, United Kingdom
Regulatory Affairs Dr Boris Pimentel, DNP (DSM-Nutritional Products), Switzerland
FDA Compliance Daniel Scheidegger, Genzyme Pharmaceuticals, Switzerland

Author: Daniel Scheidegger Chairman, European Compliance Academy (ECA)

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 Annual Review 2009 - Individual Membership

Constant interest in ECA’s Interest Groups
The ECA’s first interest group – the European Qualified Person Association – has been growing steadily since its foundation in 2006. In 2009 the number of members grew again by more than 20%. End of the year the Association looked at close to 1.200 full members and almost 90 associate members – representing nearly 40 countries worldwide.

ECA Annual Review 2009 - EQPA Members

In 2008 the interest group was invited to the European Medicines Agency’s (EMA) Inspectors Working Group Interested Parties Meeting for the first time and was re-invited in 2009, providing substantial input to joint industries responses to several issues like inconsistencies in GMP interpretation in the various Member States. This input was based on comprehensive feedback to various surveys conducted by the EQPA. The results of these surveys are a recognized source of information for authorities, industry and other organisations (EFPIA, EIPG…).

Initially started in 2008, the QP Association also worked on the next generation of its shared audits database “QPSHARE” which is supposed to be released in March 2010. With this database exclusively available for members QPs are able to instantly and easily identify suppliers and the number of other QPs interested in auditing these suppliers.

One of the first activities of the group was the development of the Good Practice Guide “Duties and Responsibilities for Qualified Persons in the EU”. In 2009 this guide was revised and published as version 2.0.

Alike the QP Association the Rapid Microbiology Method (RMM) Group has been experiencing an increasing awareness. By end of 2009 the group counted 230 members from Europe and abroad.

ECA Annual Review 2009 - Rapid Microbiology Method (RMM) Group

The first time RMM Conference conducted in December 2009 attracted more than 80 delegates. For 2010 it is planned to further raise awareness for the group, e.g. by developing a series of articles.

One of the group’s goals is to support members by collecting data on available RMM systems on the market. In 2009 the group published the first database version in its members area on the ECA website. The database covers the search criteria microbial target group, the target analysis, the range of application, the analytical method as well as the detectable micro organisms and the development status. It also comprises costs for systems and per sample, a short description and a direct link to the supplier.

Publications
GMP Guideline Manager Version 11.0 with new web-based software

With the new release 11.0, the GMP Guideline Manager became a web-based solution. This means no additional software is needed to run the application. It is displayed simply by using a web browser. As a further advantage of the new release it is possible to use a search engine designed for web browsers. After starting the software, the table of contents is displayed, enabling users to simply call up any of the guidelines or to conduct a quick search for individual guidelines, for all guidelines referring to a particular topic or to start a full-text search. The GMP guidelines database contains the complete texts, which users can also print out.

The GMP Guideline Manager Software contains over 1,100 GMP guidelines, including FDA, EC and ICH and concentrates on those guidelines that refer either to GMP topics or have an influence on GMP (e.g. Notice to Applicants). In total more than 10,000 pages of documentation have been structured very clearly.

The software cannot be purchased, but is a free gift for ECA Members only.

ECA GMP Certification Programme
The organisation’s Certification Programme is an acknowledged opportunity to advancing one’s college and university education. It continues to enjoy an excellent reputation within Europe's pharmaceutical industry.

The following programmes are available:

  • ECA Certified Validation Manager
  • ECA Certified Quality Assurance Manager - Pharmaceutical Production
  • ECA Certified Quality Assurance Manager - API Production
  • ECA Certified Quality Control Manager
  • ECA Certified Pharmaceutical Engineering Manager
  • ECA Certified Computer Validation Manager
  • ECA Certified Regulatory Affairs Manager

Please see GMP and GDP Certification Programme for further information.