Design Qualification

Production
1

Who shall responsible prepare DQ ?

2

The Validation Master Plan (VMP) of the site should address who is responsible for Commissioning and Qualification activitities. It is usually the Validation team who, with their corresponding SOP, perform the Design Qualification.

Sometimes, qualification activities can be done by qualified suppliers, and often, the equipment suppliers can provide it as part of the package. Please, if this is the case, make sure of the following:

  • The supplier is qualified as a qualification/validation service supplier
  • The Validation team reviews and authorizes the supplier documentation (in this case DQ) to confirm it complies with Validation requirements and any other requirement derived from your quality management system (QMS)

I hope this helps.

3

This topic was automatically closed 10 days after the last reply. New replies are no longer allowed.