Since the ECA Foundation was established back in 1999 its mission has been 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. For that purpose the ECA has initiated and established various working and interest groups concentrating on different topics.
The ECA Validation Group was founded in autumn 2011 by representatives of the pharmaceutical industry after ECA´s 4th European GMP Conference. This group's mission is to assemble knowledge on Validation, for example by continuously developing ECA´s Process Validation Good Practice Guide.
Now the group launched its new website to provide members and those interested with information and practical tools. Here's what you can find on the new website:
Members of the group have now the opportunity to download the version 2 of ECA´s Good Practice Guide on Validation free of charge. On 174 pages the revised Good Practice Guide comprises the main elements of the new validation approach ("what to do"). On the other hand, it also serves as a supporting guide for the implementation ("how to do").
To find out more we invite you to visit the ECA´s Validation Group new website.