ECA Foundation

ECA Working Groups - Validation Group

About us

Since the 80s Validation has been one of the most important topics in the GMP environment. State of the art is the FDA Guidance for Process Validation from 2011. The FDA favourites a Life Cycle Approach with a 3-stage model focused on process knowledge and process understanding. Statistics is also mentioned explicitly. The EMA has drafted a revision of their Note for Guidance on Process Validation which goes in the direction of the FDA. But there are some differences. EMA still accepts a traditional approach; even the magic three runs are mentioned. Legacy products are not covered by EMA´s draft. Vice versa EMA stresses more ICH Q8 with the Continuous Process Verification. How to deal with these differences? How to implement a Process Validation Life Cycle to show process knowledge and process understanding? The ECA´s Chairman has decided to establish a new ECA Working Group on Process Validation. The new group defined a whole set of goals and objectives:

  • Provision of a European wide networking platform for professionals from the pharmaceutical and API industry who deal with Process Validation.
  • Promotion of active discussion of the latest regulatory requirements for Process Validation within the European Union and US.
  • Identification and addressing of technical issues and challenges within the field of Validation including training needs.
  • Active support for a harmonised approach to common problems and issues by the generation of discussion/position papers and generic procedures via expert working groups.
  • Facilitation of effective and efficient communication between industry and competent authorities
The interest of the group and the topics it intends to concentrate on are:
  • Process Validation Life Cycle
  • Process Knowledge and Process Understanding
  • Statistics (e.g. SPC)
  • Modern Qualification

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