The ECA was established in January 1999 as an independent not-for-profit organisation. From the start its mission was “to provide support to the Pharmaceutical Industry and Regulators to promote the move towards a harmonised set of GMP and regulatory guidelines by providing information and interpretation of new or updated guidances”. This mission also remains the same with the organisation’s transfer to a Foundation in the beginning of 2010.
The Foundation’s educational organisation, the
ECA Academy, continuously organises a wealth of international education courses, conferences (also as part of a
GMP Certification Programme) and webinars around GMP and regulatory compliance, picking up emerging GMP challenges and currently discussed subjects. While the courses and webinars are designed to provide continuous education for GMP professionals in production, quality control, quality assurance etc, the European conferences are organised as discussion forums on new trends and developments.
Another free service is a
regular GMP Newsletter, supplying information on current GMP trends. As of end of 2015 more than 20.000 professional already signed up for this information tool, and numbers are steadily increasing.
GMP Guidelines Manager CD
The organisation also develops and publishes the
GMP Guidelines Manager CD. This CD comprises more than 10.000 pages of guidelines issued by the most important medicines authorities and organisations worldwide – including Warning Letters and presentations. It is thus the most comprehensive summary of global guidances. A comfortable search function allows users to browse the complete CD content by key words and to directly retrieve guidelines and regulations they are specifically interested in. This annually updated CD cannot be purchased, but it is free of charge for all ECA Members.
GMP Matrix (Good Practice Guide)
With literature like
Good Practice Guides, GMP Guidelines as Paperbacks and the GMP Journal the ECA further supports professionals in the industry in their day to day work. For instance, the GMP Matrix (Good Practice Guide) aims at establishing a relationship between the US-American cGMP rules for drug products and the EU 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 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 Compliance Website
Today, the ECA’s website at www.gmp-compliance.org is the worldwide platform for research on and interpretation of the regulations regarding pharmaceutical quality assurance and regulatory compliance.
Interest and Working Groups
In addition to the ECA Academy, the Foundation also maintains various active
interest and working groups – such as the European Qualified Person Association, the RMM Group, QC Group and others.