9. Qualification and validation protocols

9.1 There should be qualification and validation protocols describing the qualification and validation study to be performed.

9.2 As a minimum the protocols should include the following significant background information:

- the objectives of the study

- the site of the study

- the responsible personnel

- description of SOPs to be followed

- equipment to be used; standards and criteria for the relevant products and processes

- the type of validation

- the processes and/or parameters

- sampling, testing and monitoring requirements

- predetermined acceptance criteria for drawing conclusions.

9.3 There should be a description of the way in which the results will be analysed.

9.4 The protocol should be approved prior to use. Any changes to a protocol should be approved prior to implementation of the change.