Qualification and Validation Definitions

Validation

• Action of proving, in accordance with the principles of GMP, that any procedure, process, equipment, material, activity or system actually leads to the expected results

Qualification

• Action of proving that any premises, systems and items of equipment work correctly and actually lead to the expected results

(Validation usually incorporates the concept of qualification)

There are a number of definitions of validation - all of which say the same thing in different ways. The definition on this slide is the one given in the WHO GMP texts. There is a more expanded version in the WHO text on the validation of manufacturing processes:

The collection and evaluation of data, beginning at the process development stage and continuing through the production phase, which ensure that the manufacturing processes - including equipment, buildings, personnel and materials - are capable of achieving the intended results on a consistent and continuous basis.

Validation is the establishment of documented evidence that a system does what it is supposed to do.

There are three key points to take from these definitions:

1. The evidence must be documented. (The results of the validation must be recorded).

2. Validation applies to several aspects of manufacturing, including e.g. process development, materials, personnel and equipment).

3. It should demonstrate that the system does what is expected of it.

Validation is carried out against a set of criteria that are defined in advance. These criteria are detailed in predefined protocol documents.