cleaning validation reports are prepared according to this SOP and regulatory requirements. QA is responsible for reviewing and approving cleaning validation reports to ensure compliance with GMP and regulatory standards.
Validation Team: Responsible for preparing the cleaning validation report, compiling data, documenting test results, and ensuring that the report is accurate and complete.
Production Supervisors: Oversee the execution of cleaning validation activities, ensuring that operators follow the validated cleaning procedures and that the documentation is accurate and complete.
Regulatory Affairs: Ensures that the cleaning validation reports comply with applicable regulatory standards and guidelines.

4) Procedure

The following steps should be followed for preparing cleaning validation reports:

1. Report Preparation:
1.1 Begin by compiling the results of all cleaning validation activities conducted, including swab sampling, rinse sampling, microbiological testing, and residue testing.
1.2 The cleaning validation report should include the following sections:
– Introduction: A summary of the cleaning validation activity, including the objectives, scope, and specific equipment or areas validated.
– Methods and Procedures: A detailed description of the cleaning process and the methods used for cleaning validation, such as swab sampling, rinse sampling, or microbiological testing.
– Test Results: The results of all testing performed, including swab results, microbial load, residue levels, and comparison to acceptance criteria.
– Deviations: Documentation of any deviations from the validated cleaning process, including their causes and corrective actions taken.
– Conclusion: A summary of the findings, confirming whether the cleaning process meets the required acceptance criteria and is effective for future use.
1.3 Include a statement indicating that the cleaning validation activities have been performed according to the approved protocol and that all results meet the specified acceptance criteria.
1.4 Provide a section for signatures, including those of the operator, validation team, and QA, confirming the accuracy and completeness of the report.
1.5 The report should be submitted for review and approval by the appropriate stakeholders, including QA, production management, and regulatory affairs.

2. Data Collection and Documentation:
2.1 Ensure that all data collected during the cleaning validation activities is accurate, complete, and documented in a traceable manner. This includes recording test results, sampling locations, and any observations made during the testing process.
2.2 Each result should include the date, time, operator initials, and the conditions under which the test was performed (e.g., equipment ID, cleaning agent used, temperature).
2.3 Any deviations or discrepancies from the validated cleaning process should be clearly documented in the report, including the corrective actions taken to address the issue.
2.4 Ensure that all documentation is legible and properly formatted. Correct any errors or omissions in the documentation by following the appropriate change control procedures and ensuring that all corrections are signed and dated.

3. Report Review and Approval:
3.1 After the cleaning validation report is completed, it should be reviewed by the validation team to ensure that all data is accurate, complete, and consistent.
3.2 QA should review the cleaning validation report to ensure that it meets regulatory requirements and that the cleaning process is in compliance with GMP standards.
3.3 The report should be reviewed for any deviations or corrective actions and ensure that they are properly addressed and documented.
3.4 The report should be approved by the relevant stakeholders, including QA, production management, and regulatory affairs.
3.5 Ensure that all reports are signed by the personnel responsible for executing the cleaning validation activities, reviewing the report, and approving the final document.

4. Archiving and Retention:
4.1 Ensure that all cleaning validation reports are properly archived and stored in a secure system that allows for easy retrieval during audits or inspections.
4.2 Maintain the cleaning validation reports for the required retention period, as specified by regulatory guidelines or company policies.
4.3 Ensure that archived reports are protected from damage, loss, or contamination and are accessible only to authorized personnel.
4.4 Periodically review the archived reports to ensure compliance with the document retention policy and regulatory requirements.

5) Abbreviations

• QA: Quality Assurance
• GMP: Good Manufacturing Practice
• SOP: Standard Operating Procedure
• VMP: Validation Master Plan

6) Documents

• Cleaning Validation Protocol
• Cleaning Validation Report
• Test Data and Results
• Deviation and Corrective Action Reports
• Approval Forms
• Archiving and Retention Records

7) Reference

• FDA Guidance for Industry: Equipment Cleaning and Sanitation
• International Council for Harmonisation (ICH) Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• ISO 9001: Quality Management Systems – Requirements
• USP Chapter 1072: Cleaning and Sanitization of Manufacturing Equipment

8) SOP Version

Version 1.0 – Effective Date: DD/MM/YYYY

Annexure

Template 1: Cleaning Validation Report Template

Report ID	Version	Date	Prepared By	Reviewed By	Approved By
Report ID	Version	DD/MM/YYYY	Prepared By	Reviewed By	Approved By

Template 2: Deviation Report Template

Deviation ID	Deviation Description	Root Cause	Corrective Actions	Follow-Up
Deviation ID	Deviation Description	Root Cause	Corrective Actions	Follow-Up