Validation documentation
Article 52
1. A written validation protocol, specifying how validation of a particular process will be conducted, shall be established. The protocol shall be reviewed and approved by the quality unit and other designated units. 2. The validation protocol shall specify: (a) the critical process steps and acceptance criteria; (b) the type of validation to be conducted (e.g. prospective, concurrent); (c) the number of process runs. 3. A validation report that refers to the validation protocol shall be prepared. That validation report shall contain: (a) a summary of the results obtained; (b) any deviations from the validation protocol observed; (c) comments and conclusions on the deviations under point (b); (d) recommendations for change to correct deficiencies. 4. Any deviations from the validation protocol shall be documented with appropriate justification.