Commissioning validation and qualification

August 28, 2017

Over time I have been in numerous conversations with people who have shown some confusion over the terms commissioning, validation and qualification.

These terms are used in the pharmaceutical industry on a daily basis (usually by a quality manager). While pharmaceutical companies have a good grasp of these terms and the associated requirements, in many other industries this type of quality control may not have yet been considered.

Even amongst the cleanroom industry, depending on who you’re talking to, and which standards they read from, there can be discussion over these terms.

Below I have included some simplistic definitions to help clear the confusion.

Commissioning: a process or service provided to validate the completeness and accuracy of the project, or a quality assurance program intended to demonstrate a Cleanroom/Cleanroom Suite/Laboratory is constructed well and performing as designed.

Validation: the process by which the reliability and relevance of a particular approach, method, process or assessment is established for a defined purpose.

Qualification: the action in proving that any premises, system and item of equipment works correctly and actually leads to the expected results.

To minimise the number of comments I am likely to receive on this subject. I will further say that qualification has four different stages – the design qualification (DQ), installation qualification (IQ), operation qualification (OQ) and performance qualification (PQ).

A good place to go to get further understanding on this subject is at the following link World Health Organisation (WHO) publication WHO Technical Report Series 937 WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS