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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 favours a Life Cycle Approach with a 3-stage model focused on process knowledge and process understanding. Statistics is also mentioned explicitly. The EU has published a revised Annex 15, which has been valid since 1st October 2015. This Annex goes in the direction of the FDA and emphasizes a life cycle approach. Harmonisation aspects were one reason for the Annex 15 revision. But there are still some differences between the USA and EU. The traditional DQ-IQ-OQ-PQ-model is still mentioned in the Annex 15. It also still accepts a traditional validation approach; even the magic three runs are mentioned. Further, legacy products are not explicitly covered. Vice versa the Annex 15 stresses more ICH Q8 with the Continuous Process Verification. And the rate of statistic requirements is different in the FDA Guidance and the Annex 15. Thus, there are some questions to be answered: How do these differences need to be handled? How can a Process Validation Life Cycle be implememted to show process knowledge and process understanding?
To facilitate and advance discussions and to find answers the Foundation decided to establish a new ECA Interest Group on 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 discussions 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)
Board of Directors:
The members of the ECA Validation Group Advisory Board are:
Mr Gert Moelgaard (Head of the group) Mølgaard Consulting, Member of the ECA Foundation Advisory Board
Dr Jean-Denis Mallet NNE Pharmaplan
Mr Richard M. Bonner
Qualified Person, Chairman of the ECA Foundation Advisory Board
Dr Thomas Schneppe
Bayer Pharma AG
Mr Sven Pommeranz