EU GMP Annex 15 Revisions: Improving Qualification and Validation

There are subtle differences between the terms ‘validation’ and ‘qualification’. Validation is establishing documented evidence to provide a high degree of assurance that a specific system, process or facility will consistently produce a product meeting its predetermined specifications and quality attributes. Qualification is a process of assurance that the specific system, premises or equipment is able to achieve the predetermined acceptance criteria to confirm the attributes of what it purports to do.

Qualification is about documented evidence that a specific equipment, facility or system is fit/ready for intended use and validation is documenting that the way the equipment, facility or system is used will result in a system meeting its predetermined specifications and quality attributes. To put it simply, things are qualified – equipment, systems and so forth – and process and procedures (the way we use things) are validated.

Examples of things that are qualified include HVAC, pharmaceutical grade water, compressed air lines and so on. Calibration is also a part of qualification. Qualification would also apply to the training of a laboratory technician to run an assay. Examples of validation include manufacturing processes, cleaning processes, or an analytical method.

Formal validation and qualification are both requirements of GMP. Within Europe, the accepted regulatory approach is set out in Annex 15 of the EU GMP Guide. The European Commission has recently published a draft version of Annex 15.¹ The consultation document is available on the Commission’s website, where the draft takes the form of a concept paper. The draft is currently available for public comment and a final version is expected during 2014. This article discusses some of the main changes that are being proposed for the Annex.