Qualification and Validation Principle

• Essential part of GMP

• Manufacturer to identify what qualification and validation work is required

• Prove that critical aspects of work are controlled

• Key elements of qualification and validation defined and documented

Validation is an essential part of GMP. There are two main reference sources in the WHO documentation relating to validation. Firstly, the WHO GMP text covers validation in section 4 of the general GMP text. Then there is a second document on Validation that describes recommended practices for validation and qualification (40^th Report of the Expert Committee).

Manufacturers should identify what validation and qualification work should be done. All systems, equipment, processes, procedures should be reviewed and the manufacturer should decide what qualification and validation work needs to be performed. The intention is to prove that all critical aspects of the work are controlled, and perform as required.

Validation and qualification work must be documented.