Checklist for Cleaning Validation
CLEANING VALIDATION CHECKLIST
🧾 1. Documentation & Planning
- Cleaning Validation Master Plan (CVMP) approved
- Cleaning procedures/SOPs available and current
- Risk assessment performed (worst-case product, equipment, and cleaning scenario)
- Protocol approved by QA, QC, and Production
- Acceptance criteria defined (e.g., limits for API, microbial, cleaning agents)
🏭 2. Equipment Selection
- List of all equipment and product-contact surfaces
- Equipment design reviewed for cleanability
- Dedicated or multi-product use identified
- Worst-case equipment identified and justified
🧪 3. Sampling & Testing
- Sampling method defined (swab, rinse, direct)
- Sampling tools and locations validated
- Swab/rinse recovery studies conducted
- Analytical method validated for sensitivity and specificity
- Detection limits below acceptance criteria
- Microbial sampling included (bioburden or endotoxin, where applicable)
📊 4. Execution of Cleaning Validation Runs
- Minimum 3 consecutive successful cleaning runs conducted
- Each run documented with batch records, cleaning logs, and equipment usage
- Sampling performed after worst-case conditions (e.g., maximum dirty hold time)
- Personnel performing cleaning trained and qualified
- Environmental conditions recorded
📈 5. Acceptance Criteria
- Limits set for:
- Residual API
- Cleaning agent
- Bioburden/microbial load
- Visual cleanliness
- Limits based on:
- Therapeutic dose (e.g., MACO calculation)
- 10 ppm or visually clean criteria
- Toxicology data (NOEL/LD50)
📂 6. Review & Report
- All test results within defined limits
- Deviations or anomalies investigated and documented
- Cleaning validation report prepared and approved
- Trend analysis or periodic verification program in place
- CV status logged in equipment files (validated or not)
🔁 7. Revalidation Triggers
- Change in equipment or cleaning procedure
- New product introduction
- Failure in routine cleaning verification
- After major maintenance or extended shutdown
- Periodic revalidation schedule defined