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
The interest of the group and the topics it intends to concentrate on are:
- 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
- Facilitation of effective and efficient communication between industry and
- Process Validation Life Cycle
- Process Knowledge and Process Understanding
- Statistics (e.g. SPC)
- Modern Qualification
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