ENBIS-16 in Sheffield

11 – 15 September 2016; Sheffield Abstract submission: 20 March – 4 July 2016

The Role of DoE within the Process Development and Validation Lifecycle - Searching for a Balance between Experimental Effort and too High Risk

12 September 2016, 11:50 – 12:10


Submitted by
Stefanie Feiler
Stefanie Feiler (AICOS Technologies AG)
The process validation lifecycle approach of the FDA (2011) splits the process validation into the three stages process validation, process qualification and process verification. It is stressed that "knowledge and understanding is the basis for establishing an approach to control of the manufacturing process that results in products with the desired quality attributes". The lifecycle approach to process validation "employs risk based decision making throughout that lifecycle".

The necessary knowledge and understanding "can be gained by application of, for example, formal experimental designs, process analytical technology (PAT), and/or prior knowledge." (ICH Q8(R2))

Besides incorporating prior knowledge, systematic experimentation starting from the very first development stage of the process is therefore the main tool for generating initial process insight.

The big question is how much experimentation is necessary at which step of the process development. A detailed investigation in the lab still does not guarantee that the process behaves in exactly the same way after the scale up to the pilot plant or production scale.

In this talk, we discuss how risk-based considerations can be used in order to find a pragmatic compromise between the extremes of defining a detailed design space in the lab and "do at most four experiments and have a quality process up and running".
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