Qualification and validation protocols
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.