Monday, 28 April 2014

Revision to EU GMP Annex 15: Qualification and Validation

EU GMP Annex 15, which relates to the important area of qualification and validation, is being revised. Tim Sandle has undertaken an analysis of the chapter and this has been reported to the current edition of Clean Air and Containment Review (CACR).

CACR is an indispensable guide to cleanrooms and clean air technologies, edited by John Neiger. The current issue also features article on gaseous decontamination of clean air devices, a review of diffuser performance in cleanrooms, a history of isolator and containment technology Part 1: Early containment leading to flexible film isolators, and carbon dioxide based solutions for cleanroom garment.

For further details about the current issue, please CACR.

Tim Sandle’s reference is:

Sandle, T. (2014) Revision to EU GMP Annex 15: Qualification and Validation, Clean Air and Containment Review, Issue 18, pp22-23

Posted by Tim Sandle