validation protocol, and ensuring that records are generated in compliance with the validation process.

Document Control: Responsible for managing the storage, access, and retrieval of cleaning validation records in compliance with the company’s document retention policy.

Health and Safety Officer: Ensures that proper safety protocols are followed during cleaning validation activities and that safety-related information is properly documented in the records.

4. Accountability

The Manufacturing Manager is accountable for ensuring that all cleaning validation activities are documented properly and that cleaning validation records are maintained according to this SOP. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Creation of Cleaning Validation Records

1. For each cleaning validation study, generate a Cleaning Validation Protocol that includes:
   • The machine types and components to be cleaned
   • Cleaning agents and methods to be used
   • Sampling techniques and locations for residual testing
   • Acceptance criteria for cleaning validation (residual product levels, cleaning agents)
   • The testing methods to be used to detect residues (e.g., HPLC, spectrophotometry, etc.)
2. Ensure that the Cleaning Validation Protocol is reviewed and approved by the relevant departments (Production, QC, Validation, and QA) before execution.
3. Once the cleaning process is completed and samples have been collected, create the Cleaning Validation Record to document the sampling results, test results, and any deviations from the protocol.

5.2. Documentation of Sampling and Test Results

1. Record the details of each sampling event, including:
   • Sample ID and location
   • Sampling method used (e.g., swab, rinse water, etc.)
   • Operator name and date of sampling
2. Document the test results, including:
   • The test method used (e.g., HPLC, UV spectrophotometry)
   • The results of the tests, including the detection levels of product residues or cleaning agents
   • Whether the test results meet the established acceptance criteria
3. Ensure that the test results are reviewed and signed off by the QC team and that any deviations from the acceptance criteria are documented and addressed in the Deviation Report (Annexure-1).

5.3. Review and Approval of Cleaning Validation Records

1. All cleaning validation records must be reviewed by the QA department to ensure compliance with this SOP and GMP standards.
2. After the review, the QA team must approve the cleaning validation record and file it for future reference.
3. Ensure that any issues, such as failed tests or deviations, are investigated and documented in the deviation records. Corrective actions must be taken and validated accordingly.
4. All validation records must be stored in the appropriate document management system, with access controlled to maintain confidentiality and prevent unauthorized access.

5.4. Retention and Retrieval of Cleaning Validation Records

1. Cleaning validation records must be retained in accordance with the company’s document retention policy, which ensures that records are kept for the required period (typically a minimum of 5 years).
2. Ensure that records are organized and indexed to facilitate easy retrieval during internal audits, regulatory inspections, or quality reviews.
3. Ensure that all records are stored in a secure location, either physical or electronic, and that proper backups are in place to prevent data loss.

5.5. Environmental Considerations

1. Ensure that all cleaning validation activities are performed in a manner that minimizes environmental impact, including proper handling and disposal of cleaning agents and solvents.
2. Document any environmental considerations in the Cleaning Validation Record, such as waste disposal methods for cleaning agents and solvents used during validation studies.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure
• HPLC: High-Performance Liquid Chromatography
• MSDS: Material Safety Data Sheet

7. Documents

1. Cleaning Validation Protocol (Annexure-1)
2. Cleaning Validation Record (Annexure-2)
3. Deviation Report (Annexure-3)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems
• Environmental Protection Agency (EPA) Regulations

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cleaning Validation Protocol

Protocol ID	Machine Type	Operator Name	Cleaning Agent Used	Validation Date
CVP-001	Filling Machine	Rajesh Patel	Solvent A	06/02/2025

Annexure-2: Cleaning Validation Record

Sample ID	Test Method	Test Results	Acceptance Criteria	Remarks
SVR-001	HPLC	Pass	< 5 ppm	No deviation

Annexure-3: Deviation Report

Deviation ID	Deviation Description	Corrective Action Taken	Operator Name	Validation Date
DV-001	Residual cleaning agent above limit	Re-cleaned machine with stronger solvent	Rajesh Patel	06/02/2025

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated validation process and criteria	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures