Cleaning Validation Report TEMPLATE
Cleaning Validation Report TEMPLATE
Document code:
Version:
Date:
Number of pages:
Equipment
Serial number
Identification number
Document code:
Company logo
CLEANING VALIDATION REPORT
Equipment: Page: 2 of 9
CONTENT
1. CLEANING NO.1
1.1.General data
1.6. Appendices
2. CLEANING NO.2
2.1.General data
2.6. Appendices
3. CLEANING NO.3
3.1.General data
3.6. Appendices
4. SUMMARY
Document code:
Company logo
CLEANING VALIDATION REPORT
Equipment: Page: 3 of 9
CLEANING NO.1
Product name:
Batch number:
Acceptance limit:
Sampling point Date / time of Sampled by Result Passed ( ) /
sampling Failed ( x )
Acceptance limit:
Sampling point Date / time of Sampled by Result Passed ( ) /
sampling Failed ( x )
Equipment: Page: 4 of 9
Each participant of the Validacion team is trained for performing of the appropriate activity.
The records from the performed trainings for each participant are in the Personal dossier for training.
1.6. APPENDICES
CLEANING NO.2
Document code:
Company logo
CLEANING VALIDATION REPORT
Equipment: Page: 5 of 9
Product name:
Batch number:
Acceptance limit:
Sampling point Date / time of Sampled by Result Passed ( ) /
sampling Failed ( x )
Acceptance limit:
Sampling point Date / time of Sampled by Result Passed ( ) /
sampling Failed ( x )
Equipment: Page: 6 of 9
Each participant of the Validacion team is trained for performing of the appropriate activity.
The records from the performed trainings for each participant are in the Personal dossier for training.
2.6. APPENDICES
CLEANING NO.3
Equipment: Page: 7 of 9
Product name:
Batch number:
Acceptance limit:
Sampling point Date / time of Sampled by Result Passed ( ) /
sampling Failed ( x )
Acceptance limit:
Sampling point Date / time of Sampled by Result Passed ( ) /
sampling Failed ( x )
Equipment: Page: 8 of 9
Each participant of the Validacion team is trained for performing of the appropriate activity.
The records from the performed trainings for each participant are in the Personal dossier for training.
3.6. APPENDICES
Equipment: Page: 9 of 9
4. SUMMARY
The efficancy of the cleaning procedure is confirmed with the obtained results from the
samplings for residues of the active pharmaceutical ingredient, cleaning agent and
microbiological cotamination, which are performed after the cleaning of the equipment.
All results are inside the determined acceptance limits.
- The maximum holding time between the end of production and start of cleaning is __
hours. During this time, the operators are obliged to start the cleaning process.
- The maximum holding time after cleaning until the equipment is used again is
__hours. Beyond this time, the equipment must be disinfected before use.
Following all the above mentioned, the Procedure for cleaning of the _____(Name of
equipment)____ is succsessfully validated, according to the requirements of EU GMP,
Annex 15, and can be applied on all products which are manufactured on this equipment.
Responsible
Name and Position Date Signature
persons
surname
Quality Assurance
Department
Production
Department
Quality Control
Department
Quality Assurance
Department