and reviewing cleaning effectiveness. The QC team also ensures that the validation process complies with GMP and regulatory requirements.

Validation Team: Responsible for designing, conducting, and documenting cleaning validation studies, including sampling techniques, testing methods, and acceptance criteria for cleaning effectiveness.

Health and Safety Officer: Ensures that all cleaning validation activities are performed in compliance with safety guidelines, especially regarding the handling of cleaning agents and solvents.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed and that cleaning processes are validated according to the prescribed procedure. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Cleaning Validation Protocol

1. Develop a cleaning validation protocol that outlines the validation strategy, including the objectives, scope, cleaning agents and methods to be validated, and acceptance criteria for cleaning effectiveness.
2. The protocol should define the following:
   • Machine types and components to be validated
   • Cleaning agents and methods to be used
   • Sampling methods for residual testing
   • Testing methods for detecting product residues and cleaning agent residues
   • Acceptance criteria for residual levels
   • Frequency of cleaning validation studies (e.g., after every change in product, after a specified number of runs, etc.)
3. Review and approve the cleaning validation protocol before commencing validation activities.

5.2. Conducting Cleaning Validation

1. After the machine has been cleaned, collect samples from various machine surfaces to check for any residual contamination. This can include:
   • Swabbing the machine surfaces
   • Collecting rinse water or solvent samples after cleaning
2. Use validated testing methods to analyze the samples for residual product or cleaning agents. Common testing methods include:
   • High-Performance Liquid Chromatography (HPLC)
   • Spectrophotometry
   • Conductivity testing for residual cleaning agents
3. Compare the results to predefined acceptance criteria for cleaning effectiveness. Acceptance criteria should be established based on safety limits for residual contamination, typically defined as a percentage of the allowable residue or a specific limit defined by regulatory guidelines.
4. If the results meet the acceptance criteria, the cleaning process is deemed validated. If not, repeat the cleaning process and sampling until the criteria are met.

5.3. Documentation of Cleaning Validation

1. Document all cleaning validation activities, including the protocol, sampling results, test results, and any deviations or corrective actions taken during the validation process.
2. Ensure that all documentation is accurate, complete, and signed by the personnel involved in the cleaning validation process.
3. Store the validation records as per the company’s document retention policy, making them available for internal audits, regulatory inspections, and quality control reviews.

5.4. Ongoing Monitoring and Revalidation

1. Once the initial cleaning validation has been completed, ongoing monitoring is necessary to ensure that the cleaning process remains effective over time. This can include periodic sampling and testing at regular intervals or after any changes to the product or machine setup.
2. Revalidate the cleaning process after:
   • Changes in product formulation
   • Changes in the cleaning process or cleaning agents
   • Long periods of non-use of the equipment
   • New equipment or machine parts are introduced
3. Conduct revalidation studies according to the protocol and document the results for continuous monitoring and compliance purposes.

5.5. Safety and Environmental Considerations

1. Ensure that cleaning validation activities are conducted in a safe and environmentally responsible manner. Use appropriate PPE such as gloves, goggles, and aprons when handling cleaning agents and solvents.
2. Ensure that all cleaning agents and solvents used in validation studies are compatible with the materials of the machine and are disposed of according to environmental and safety regulations.
3. Ensure proper ventilation when using cleaning agents or solvents to avoid exposure to harmful fumes or vapors.

6. Abbreviations

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

7. Documents

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

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	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: Post-Validation Report

Report ID	Test Date	Machine ID	Validation Status	Operator Name
PVR-001	06/02/2025	F-12345	Validated	Rajesh Patel

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