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.”
Posted by Tim Sandle
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