Hello good people of the world! On February 6, 2014 the European Commission released a draft revision of EudraLex Volume 4, Annex 15 “Qualification and Validation” for comments.
The previous version (latest approved at the time of this blog post) is available here.
The new draft version is here.
General: the guidance has increased from 11 pages to 17, with added sections on “Verification of Transportation,” “Validation of Packaging,” “Qualification of Utilities,” “Validation of Test Methods,” and “Cleaning Validation.”
Detailed differences in each section are highlighted below. Continue reading EU Guidance Revision: EudraLex Volume 4, Annex 15, Qualification and Validation