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EudraLex Vol 4: New Annex 15: Qualification

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From 1 October 2015, the revision to Annex 15 of EudraLex Vol 4 comes into operation, qualification and validation. Annex 15 has been in effect since 2001, so a revision was long overdue. In addition to the revision, there is also a major extension: the new guideline comprises 16 pages, compared to 11 prior to the revision. This postpost briefly discusses part 3 of this revised Annex: Qualification stages for equipment, facilities, utilities and systems.

What is striking is that a number of steps which have been used in the industry for quite some time, have now also been incorporated in the Annex. Included in this version, as opposed to the previous one, are URS (User Requirements Specification) and FAT (Factory Acceptance Testing)/SAT (Site Acceptance Testing). The explanation of the URS explicitly states ‘should be’, compared to ‘may be’ in the FAT/SAT. Carrying out a FAT is therefore clearly not compulsory. The revised Annex also offers the option of a combined Installation (IQ) and Operation Qualification (OQ) as an IOQ.

Qualification of established (in-use) facilities, systems and equipment (see also ‘retrospective validation’ in a later post) has disappeared, and is therefore no longer allowed.

After part 3, Qualification, a new part 4 was added, requalification. Equipment, facilities, utilities and systems ‘should be’ evaluated to confirm that they remain in a state of control. The period for requalification and the criteria used have to be defined, small changes in between have to be evaluated.

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