生命科学 eQMS 17 项

Cleaning Validation Checklist (21 CFR 211.67 / ICH Q7)

此检查清单为英文版。

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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