SOP for Cleaning Validation Records
Department | Aerosol |
---|---|
SOP No. | SOP/Aerosol/055/2025 |
Supersedes | SOP/Aerosol/055/2022 |
Page No. | Page 1 of Y |
Issue Date | 06/02/2025 |
Effective Date | 16/02/2025 |
Review Date | 06/02/2028 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the requirements for the documentation and maintenance of cleaning validation records in aerosol manufacturing. The objective of this SOP is to ensure that all cleaning validation activities are thoroughly documented, traceable, and compliant with regulatory standards. Proper documentation of cleaning validation records helps ensure product safety, quality, and compliance with Good Manufacturing Practices (GMP) standards.
2. Scope
This SOP applies to the documentation and record-keeping of cleaning validation activities for all aerosol manufacturing equipment, including filling machines, crimping machines, and other production-related equipment. It covers the creation, management, retention, and review of cleaning validation records, including sampling, testing, and validation results. This SOP does not cover routine cleaning activities or non-validation related cleaning records.
3. Responsibilities
- Production Team: Responsible for maintaining accurate records of cleaning validation activities, including sampling and testing results, and ensuring all documentation is submitted to the appropriate department.
- Quality Control (QC) Team: Responsible for reviewing cleaning validation records, ensuring that cleaning tests meet the required standards, and ensuring compliance with GMP regulations.
- Validation Team: Responsible for conducting cleaning validation studies, preparing the cleaning 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
- 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.)
- Ensure that the Cleaning Validation Protocol is reviewed and approved by the relevant departments (Production, QC, Validation, and QA) before execution.
- 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
- 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
- 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
- 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
- All cleaning validation records must be reviewed by the QA department to ensure compliance with this SOP and GMP standards.
- After the review, the QA team must approve the cleaning validation record and file it for future reference.
- 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.
- 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
- 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).
- Ensure that records are organized and indexed to facilitate easy retrieval during internal audits, regulatory inspections, or quality reviews.
- 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
- 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.
- 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
- Cleaning Validation Protocol (Annexure-1)
- Cleaning Validation Record (Annexure-2)
- 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 |