생명과학 eQMS 14개 항목
GMP Deviation Management Checklist (21 CFR 211.192)
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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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