Life-Sciences eQMS 17 items
Cleaning Validation Checklist (21 CFR 211.67 / ICH Q7)
Confirms that cleaning procedures for shared product-contact equipment are validated to prevent cross-contamination and carryover. Use during cleaning validation protocol review and requalification.
21 CFR 211.67ICH Q7FDA Cleaning Validation Guidance
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Program and Scope
- Is there an approved cleaning validation master plan and protocol? *
- Are equipment and product-contact surfaces defined and mapped in the protocol? *
- Is a worst-case/bracketing rationale documented (least soluble, most potent, hardest to clean)? *
Acceptance Criteria
- Are carryover limits scientifically justified (e.g., health-based/PDE, 10 ppm, dose-based)? *
- Record the calculated maximum allowable carryover (MAC) limit.
- Are visually clean criteria and microbial/endotoxin limits defined where relevant? *
Sampling and Recovery
- Are swab and/or rinse sampling locations defined and justified? *
- Have analytical method and recovery studies been validated for the sampling technique? *
- Record the recovery percentage established for the swab method.
Cleaning Procedure Execution
- Is the cleaning SOP approved and followed, including cleaning agents, concentrations, and contact times? *
- Is the dirty-hold and clean-hold time evaluated and within validated limits? *
- Are cleaning and use logs maintained for the equipment? *
Validation Runs and Results
- Were at least three consecutive successful cleaning runs completed (or a justified alternative)? *
- Do all residue results meet the established acceptance limits? *
- Are any excursions investigated and documented? *
Lifecycle Maintenance
- Is a requalification/periodic monitoring plan defined? *
- Are changes to products, equipment, or cleaning agents assessed for revalidation? *
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