생명과학 eQMS 14개 항목
Continued Process Verification (Stage 3) Checklist
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Confirms that an ongoing Stage 3 program monitors commercial process performance to ensure the process remains in a state of control after validation. Use to establish or audit continued process verification.
FDA Process Validation Guidance 201121 CFR 211ICH Q10
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CPV Plan
- Is a documented Continued Process Verification plan established following PPQ? *
- Does the plan define the CQAs and CPPs to be monitored routinely? *
- Are the statistical methods and control limits for monitoring defined? *
- Are data collection frequency and responsibilities specified? *
Data Collection and Analysis
- Are process and quality data collected and analyzed on an ongoing basis by qualified personnel (e.g., a statistician)? *
- Are control charts or equivalent statistical process control tools used to detect variability? *
- Is process capability (Cpk/Ppk) evaluated over time?
- Are within-batch and between-batch variation trends distinguished? *
Signal Detection and Response
- Are out-of-trend or adverse signals escalated and investigated? *
- Do investigations assess the need for CAPA or process improvements? *
- Is the need for revalidation evaluated when significant changes or drift are detected? *
Periodic Review and Feedback
- Is CPV output summarized and reviewed at a defined periodic frequency? *
- Are CPV findings incorporated into the product quality review and control strategy? *
- Are monitoring parameters and limits refined as process knowledge increases?
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