生命科学 eQMS 14 项

GMP Deviation Management Checklist (21 CFR 211.192)

此检查清单为英文版。

Verifies that manufacturing deviations and discrepancies are captured, risk-assessed, investigated, and resolved before batch disposition. Use for deviation record review and QA oversight.

21 CFR 211.192ICH Q7 2.5ICH Q10

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Deviation Capture

Is the deviation documented promptly with a unique identifier and description? *
Is the affected product, batch, equipment, or system identified? *
Record the date the deviation was detected. *

Classification and Risk

Is the deviation classified by severity/risk (e.g., minor, major, critical)? *
Is an immediate impact/containment assessment performed to secure affected material? *
Is a quality risk assessment documented for major/critical deviations? *

Investigation

Is a thorough investigation conducted, including root cause determination? *
Does the investigation extend to other batches/products that may be associated? *
Is the investigation completed within the defined timeframe (or extension justified)? *

Corrective Actions and CAPA Linkage

Are corrections and, where appropriate, CAPA identified and initiated? *
Are actions to prevent recurrence tracked to completion? *

Disposition and Closure

Is the batch disposition decision documented and justified by the investigation conclusion? *
Has the quality unit reviewed and approved the deviation record? *
QA approver sign-off for closure. *

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