Do the requirements of Annex 15 also apply to computerised systems or should one only look at the requirements of Annex 11 when dealing with validation of software etc.?
1 Like
Taken from Annex 15 see full text below: “computerized systems should ALSO use Annex 11 and ICH 8,9,10.”
Note: they do not state “should INSTEAD” use Annex 11.
Because of this Annex 11 AND Annex 15 AND ICH 8,9,10 are all applicable.
Principle
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.
Thank you for your reply, Jared! You confirmed my thoughts on this.
Awesome discussion guys 