Qualification and Validation Scope

• Documented evidence to prove that, e.g.

  - Premises

  - Supporting utilities

  - Equipment have been designed in accordance with GMP

• Also referred to as Design Qualification (DQ) where appropriate

Documented evidence should be provided that prove that e.g.

Premises

Supporting utilities such as water systems, air handling systems, gas supply, compressed air (where these are relevant)

Equipment have been designed in accordance with GMP and meet their user requirements/design specification needs.

Also referred to as Design Qualification (DQ) where appropriate.