Qualification and the new Annex 15 Draft

Recommendation

16-18 November 2021

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The comment period for the new Annex 15 draft "Qualification and Validation" started at the beginning of February. Still, the coming into force of the new version is planned for October 2014. Yet, as the comment period should have already begun from December 2013 on, the coming into force could also be postponed.

The consequent use of the risk management approach and lifecycle observation for validation and qualification is a central and essential issue of the new document. Qualification should now start with the creation of the user requirements URS; The Design Qualification (DQ) as verification will thus become the second step within qualification. Until now, DQ had always been described as the first step.

The reference for the first time of FAT and SAT (Factory and Site Acceptance Test) is something new whereas retrospective qualification has been completely removed. The FAT is even compulsory for more complex equipment  i.e. for their qualification.

An own new chapter entitled "Validation of utilities" is now dedicated to the qualification of media. Seasonal variations should also be considered - where applicable - in the context of qualification. For risk assessment, a difference is made between systems with direct (HVAC) and indirect (i.e. heat exchangers) contact with the product.

Also the chapter on re-qualification has now become a separate chapter and has thus become an explicit requirement. Up to now, re-qualification had only been indirectly required via re-validation. As qualification is regarded as part of validation, the requirement on regular re-validation has been transferred to re-qualification.