Standard Operating Procedure for Equipment Cleaning Verification
1) Purpose
This SOP outlines the procedures for verifying the cleaning of pharmaceutical equipment to ensure it meets cleanliness standards and prevents cross-contamination.
2) Scope
This SOP applies to all pharmaceutical manufacturing areas where equipment cleaning verification is critical to maintaining product quality and compliance with regulatory requirements.
3) Responsibilities
The Quality Assurance (QA) department is responsible for overseeing equipment cleaning verification procedures. Production personnel are responsible for performing cleaning verification.
4) Procedure
4.1 Pre-Cleaning Preparation
- Notify QA and obtain necessary approvals for equipment cleaning verification.
- Ensure all cleaning materials and equipment are available and inspected for cleanliness and functionality.
4.2 Sampling Procedure
- Select appropriate sampling locations based on equipment design and cleaning complexity.
- Use validated sampling techniques (e.g., swabbing, rinsing) to collect samples from critical surfaces.
4.3 Sample Collection
- Label sampling containers with unique identifiers and record sampling details (location, equipment ID, date, etc.).
- Collect samples following a defined sampling plan to ensure representativeness of cleaning effectiveness.
4.4 Analysis and Acceptance Criteria
- Transport samples to the laboratory for analysis according to validated analytical methods.
- Compare sample results against established acceptance criteria for cleanliness (e.g., residue limits, microbial counts).
4.5 Documentation and Record Keeping
- Document all cleaning verification activities, including sampling, analysis, and results interpretation.
- Maintain records of cleaning verification results, deviations, and corrective actions taken.
4.6 Release of Equipment
- Authorize the release of equipment for use based on satisfactory cleaning verification results.
- Ensure all documentation is complete and reviewed by QA prior to equipment release.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
6) Documents, if any
Cleaning Validation Protocol, Cleaning Verification Records, Laboratory Analysis Reports
7) Reference, if any
Regulatory guidelines such as FDA Guidance for Industry: Cleaning Validation Guidelines, EU GMP Annex 15 Qualification and Validation, PIC/S Guide to Good Manufacturing Practice for Medicinal Products
8) SOP Version
Version 1.0
