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Sie suchen in allen Bereichen nach dem Autor Feiler S.
In der Rubrik Zeitschriften haben wir 1 Beitrag für Sie gefunden
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The Role of DoE Within the Process Development and Validation Lifecycle
Rubrik: Technik
(Treffer aus pharmind, Nr. 08, Seite 1128 (2018))
The Role of DoE Within the Process Development and Validation Lifecycle / Searching for a Balance Between Experimental Effort and too High a Risk · Feiler S · AICOS Technologies AG, Allschwil, Switzerland
The process validation lifecycle approach of the FDA [ 1 ] splits 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” . As stated in ICH Q8(R2) [ 2 ], the necessary knowledge and understanding “can be gained by application of, for example, formal experimental designs, process analytical technology (PAT), and/or prior knowledge” . Citations like these are grist to the mill of Design of Experiments (DoE) advocates: ...
