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Cleaning Validation Report TEMPLATE

This cleaning validation report summarizes the results of cleaning tests on pharmaceutical production equipment. It describes three separate cleaning cycles, each including visual inspections, sampling and testing for active pharmaceutical ingredients, cleaning agents, and microorganisms. The report finds that all cleaning cycles passed acceptance criteria for removing residues and contaminants from the equipment surface.

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100% found this document useful (2 votes)
4K views9 pages

Cleaning Validation Report TEMPLATE

This cleaning validation report summarizes the results of cleaning tests on pharmaceutical production equipment. It describes three separate cleaning cycles, each including visual inspections, sampling and testing for active pharmaceutical ingredients, cleaning agents, and microorganisms. The report finds that all cleaning cycles passed acceptance criteria for removing residues and contaminants from the equipment surface.

Uploaded by

natavce
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
You are on page 1/ 9

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

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