New ECA Working Group on Process Validation starts first Project

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
  NNE Pharmaplan

• 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.