Wednesday, 30 September 2015

EU GMP Annex 15

In February 2014 the draft for the revision of Annex 15 “Qualification and Validation” was published. Now the draft has been published as final document and will be valid as of 1 October 2015.

The introduction reads:

“This Annex describes the principles of qualification and validation which are applicable
to the facilities, equipment, utilities and processes used for the manufacture of medicinal
products and may also be used as supplementary optional guidance for active substances
without introduction of additional requirements to EudraLex, Volume 4, Part II. It is a
GMP requirement that manufacturers control the critical aspects of their particular
operations through qualification and validation over the life cycle of the product and
process. Any planned changes to the facilities, equipment, utilities and processes, which
may affect the quality of the product, should be formally documented and the impact on
the validated status or control strategy assessed. Computerised systems used for the
manufacture of medicinal products should also be validated according to the
requirements of Annex 11. The relevant concepts and guidance presented in ICH Q8, Q9,
Q10 and Q11 should also be taken into account.”

For details see: EU GMP

Posted by Tim Sandle