1) SOP for Cleaning Verification
2) Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for verifying the cleaning process of equipment used in pharmaceutical manufacturing to ensure no contamination and compliance with regulatory standards.
3) Scope
This SOP applies to all personnel involved in the cleaning and verification of equipment used in the manufacturing process within the pharmaceutical facility.
4) Responsibilities
- Production personnel are responsible for performing the cleaning of equipment according to the cleaning SOPs.
- Quality Assurance (QA) personnel are responsible for verifying the effectiveness of the cleaning process.
- Supervisors are responsible for overseeing the cleaning process and ensuring compliance with the cleaning verification procedure.
5) Procedure
- Preparation
- Identify the equipment that requires cleaning and verification.
- Ensure all cleaning agents and materials are available and meet the specified requirements.
- Review the relevant cleaning SOP for the specific equipment.
- Cleaning Process
- Disassemble the equipment as required by the cleaning SOP.
- Clean all parts of the equipment thoroughly using the specified cleaning agents and methods.
- Ensure that all residues are removed, and the equipment is rinsed properly to remove any cleaning agents.
- Reassemble the equipment and perform a visual inspection to confirm cleanliness.
- Sampling for Verification
- Identify the critical points on
the equipment where residue is most likely to remain.
Collect samples using appropriate swabs or rinse methods as specified in the cleaning verification protocol.
Label all samples accurately and document the sampling process in the laboratory logbook.
Laboratory Analysis
Review and Documentation
Final Approval
- Submit the collected samples to the QA laboratory for analysis.
- Perform the required analytical tests to detect any remaining residues or contaminants.
- Document the test results and compare them against the predefined acceptance criteria.
- QA personnel should review the test results to ensure they meet the acceptance criteria.
- Document the cleaning verification results in the cleaning verification report.
- If the results do not meet the criteria, investigate the cause and repeat the cleaning process as necessary.
- Once the cleaning verification results meet the acceptance criteria, the QA manager or designated personnel should review and approve the cleaning verification report.
- Document the final approval, including the date and signature of the approving authority.
6) Abbreviations, if any
- SOP: Standard Operating Procedure
- QA: Quality Assurance
7) Documents, if any
- Cleaning SOP
- Cleaning Verification Protocol
- Laboratory Logbook
- Cleaning Verification Report
8) Reference, if any
- Current Good Manufacturing Practice (cGMP) guidelines
- Company-specific cleaning verification guidelines
9) SOP Version
Version 1.0
