Standard Operating Procedure for Cleaning Validation in Manufacturing Area
1) Purpose
The purpose of this SOP is to outline the procedures for validating cleaning processes in the pharmaceutical manufacturing area to ensure removal of residues and contaminants from equipment and facilities.
2) Scope
This SOP applies to all cleaning validation activities conducted in the pharmaceutical manufacturing facility.
3) Responsibilities
3.1 Cleaning Validation Team
- Develop and execute cleaning validation protocols based on approved procedures.
- Perform testing and analysis to confirm cleanliness of equipment and facilities.
3.2 Quality Assurance (QA) Personnel
- Review and approve cleaning validation protocols and reports.
- Ensure compliance with regulatory requirements and internal standards.
4) Procedure
4.1 Protocol Development
- Define acceptance criteria for cleanliness based on product and equipment specifications.
- Draft cleaning validation protocols including sampling methods and analytical procedures.
4.2 Pre-Cleaning Inspection
- Visually inspect equipment and facilities for visible residues or contaminants.
- Document findings and perform initial cleaning if necessary.
4.3 Cleaning Process Validation
- Execute cleaning procedures as per standard operating instructions (SOIs).
- Collect samples from critical locations and analyze for residual contaminants.
4.4 Reporting and Documentation
- Compile cleaning validation data and prepare validation reports.
- Obtain QA approval for cleaning validation results before equipment release.
5) Abbreviations, if any
QA: Quality Assurance
SOI: Standard Operating Instructions
6) Documents, if any
- Cleaning Validation Protocols
- Cleaning Validation Reports
- Acceptance Criteria Documents
7) Reference, if any
EMA Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
FDA Guide to Inspections of Validation of Cleaning Processes
8) SOP Version
Version 1.0