Company logo
CLEANING VALIDATION REPORT
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
1.2. Visual check and results
1.3. Sampling and results
1.4. Problems / Deviations
1.5. Validation team
1.6. Appendices
2. CLEANING NO.2
2.1.General data
2.2. Visual check and results
2.3. Sampling and results
2.4. Problems / Deviations
2.5. Validation team
2.6. Appendices
3. CLEANING NO.3
3.1.General data
3.2. Visual check and results
3.3. Sampling and results
3.4. Problems / Deviations
3.5. Validation team
3.6. Appendices
4. SUMMARY
Document code:
Company logo
CLEANING VALIDATION REPORT
Equipment: Page: 3 of 9
CLEANING NO.1
1.1. GENERAL DATA
Product name:
Batch number:
Date / time of end of production:
Date / time of start of cleaning:
Date / time of end of cleaning and disinfection:
1.2. VISUAL CHECK AND RESULTS
Acceptance limit: Visible residues from the product / cleaning agent must not be found on the
equipment surface
Check point Checked by Result Passed ( ) /
Failed ( x )
1.3. SAMPLING AND RESULTS
1.3.1. Test for residues of active pharmaceutical ingredient
Acceptance limit:
Sampling point Date / time of Sampled by Result Passed ( ) /
sampling Failed ( x )
The Certificates of chemical analysis are shown in Appendix 1.6.1.
1.3.2. Test for residues of cleaning agent in final rinse
Acceptance limit:
Sampling point Date / time of Sampled by Result Passed ( ) /
sampling Failed ( x )
The Certificates of chemical analysis are shown in Appendix 1.6.2.
Document code:
Company logo
CLEANING VALIDATION REPORT
Equipment: Page: 4 of 9
1.3.3. Test for microbiological contamination
Acceptance limit:
Sampling point Date / time of Sampled by Result Passed ( ) /
sampling Failed ( x )
The Certificates of microbiological analysis are shown in Appendix 1.6.3.
1.4. PROBLEMS / DEVIATIONS
1.5. VALIDATION TEAM
Name and surname Position / Department Responsibility Signature
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
1.6.1. Certificates of chemical analysis - residues of API
1.6.2. Certificates of chemical analysis - residues of cleaning agent
1.6.3. Certificates of microbiological analysis
CLEANING NO.2
Document code:
Company logo
CLEANING VALIDATION REPORT
Equipment: Page: 5 of 9
2.1. GENERAL DATA
Product name:
Batch number:
Date / time of end of production:
Date / time of start of cleaning:
Date / time of end of cleaning and disinfection:
2.2. VISUAL CHECK AND RESULTS
Acceptance limit: Visible residues from the product / cleaning agent must not be found on the
equipment surface
Check point Checked by Result Passed ( ) /
Failed ( x )
2.3. SAMPLING AND RESULTS
2.3.1. Test for residues of active pharmaceutical ingredient
Acceptance limit:
Sampling point Date / time of Sampled by Result Passed ( ) /
sampling Failed ( x )
The Certificates of chemical analysis are shown in Appendix 2.6.1.
2.3.2. Test for residues of cleaning agent in final rinse
Acceptance limit:
Sampling point Date / time of Sampled by Result Passed ( ) /
sampling Failed ( x )
The Certificates of chemical analysis are shown in Appendix 2.6.2.
2.3.3. Test for microbiological contamination
Acceptance limit:
Document code:
Company logo
CLEANING VALIDATION REPORT
Equipment: Page: 6 of 9
Sampling point Date / time of Sampled by Result Passed ( ) /
sampling Failed ( x )
The Certificates of microbiological analysis are shown in Appendix 2.6.3.
2.4. PROBLEMS / DEVIATIONS
2.5. VALIDATION TEAM
Name and surname Position / Department Responsibility Signature
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
2.6.1. Certificates of chemical analysis - residues of API
2.6.2. Certificates of chemical analysis - residues of cleaning agent
2.6.3. Certificates of microbiological analysis
CLEANING NO.3
3.1. GENERAL DATA
Document code:
Company logo
CLEANING VALIDATION REPORT
Equipment: Page: 7 of 9
Product name:
Batch number:
Date / time of end of production:
Date / time of start of cleaning:
Date / time of end of cleaning and disinfection:
3.2. VISUAL CHECK AND RESULTS
Acceptance limit: Visible residues from the product / cleaning agent must not be found on the
equipment surface
Check point Checked by Result Passed ( ) /
Failed ( x )
3.3. SAMPLING AND RESULTS
3.3.1. Test for residues of active pharmaceutical ingredient
Acceptance limit:
Sampling point Date / time of Sampled by Result Passed ( ) /
sampling Failed ( x )
The Certificates of chemical analysis are shown in Appendix 3.6.1.
3.3.2. Test for residues of cleaning agent in final rinse
Acceptance limit:
Sampling point Date / time of Sampled by Result Passed ( ) /
sampling Failed ( x )
The Certificates of chemical analysis are shown in Appendix 3.6.2.
Document code:
Company logo
CLEANING VALIDATION REPORT
Equipment: Page: 8 of 9
3.3.3. Test for microbiological contamination
Acceptance limit:
Sampling point Date / time of Sampled by Result Passed ( ) /
sampling Failed ( x )
The Certificates of microbiological analysis are shown in Appendix 3.6.3.
3.4. PROBLEMS / DEVIATIONS
3.5. VALIDATION TEAM
Name and surname Position / Department Responsibility Signature
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
3.6.1. Certificates of chemical analysis - residues of API
3.6.2. Certificates of chemical analysis - residues of cleaning agent
3.6.3. Certificates of microbiological analysis
Document code:
Company logo
CLEANING VALIDATION REPORT
Equipment: Page: 9 of 9
4. SUMMARY
The Cleaning validation of the _(Equipment Name)_________ is performed acording to the
prescribed and approved Cleaning validation protocol, on three consecutive batches of ____,
(Name of product)___which is determined as worst case product for cleaning of this
equipment.
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 following holding times are established:
- 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.
During the Cleaning validation no problems or deviations occured.
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.
Revalidation date: ________
Responsible
Name and Position Date Signature
persons
surname
Quality Assurance
Department
Production
Department
Quality Control
Department
Quality Assurance
Department
