Many members of the European Compliance Academy (ECA) have recognised that there is a paradigm shift in Process Validation. Validation is seen as Life Cycle Approach with focus on process knowledge and process understanding. Therefore, the new ECA Process Validation Working Group has defined its first project: A Good Practice Guide with the goal to provide assistance relative to the new Process Validation requirements and specifically to "what to do" and "how to do it". To accomplish this goal an advisory board was founded. Members of the Advisory Board on Validation are:
Dr. Jean-Denis Mallet
SNC Lavalin, Member of the ECA Foundation Advisory Board
Mr. Richard M. Bonner
Qualified Person, Chairman of the ECA Foundation Advisory Board
Dr. Thomas Schneppe
Bayer Pharma AG
Mr. Gert Moelgaard
Dr. Renate Schenk-Gröninger
Boehringer Ingelheim Pharma GmbH & Co. KG
The Good Practice Guide will have chapters about History of Validation, examples about how to do validation (e.g. with details on the use of statistics and risk based approach), legacy processes, process validation and biopharmaceutical API manufacturing.
Once the first draft has been developed and edited by the group´s advisory board the members of this working group will be invited to discuss the draft via a survey. Every ECA member can become a member of this group. We especially address members who are acting as QA or validaton professionals.
If you are an ECA member and interested in getting actively involved in the working group please fill in the contact form and indicate that you want to become a member of the group