Definition of cleanroom validation in accordance with GMP

• All production processes, analysis methods and cleaning processes must be validated, i.e. it must be demonstrated that these methods/processes lead to the required result in a reproducible way.
• The validation plan defines the aim, procedure and responsibilities for validation. It also defines acceptance criteria and test methods.
• Validation may only be begun when the validation plan has been approved by the responsible persons.
• If changes/additions to the validation plan are necessary during validation, these must also be approved.
• After the tests defined in the plan are carried out, a validation report is produced.The validation report must contain a conclusion on the study and be approved by the responsible persons.

Source: PTS Training Service