生命科学 eQMS 14 项
Reference Standard Management Checklist
此检查清单为英文版。
Confirms that primary and secondary (working) reference standards are qualified, characterized, stored, and controlled to ensure the reliability of analytical results. Use to audit a reference standard program.
21 CFR 211.194USP <11>ICH Q7
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Sourcing and Qualification
- Are compendial (official) reference standards used where available and current lots verified? *
- Are non-compendial primary standards characterized for identity, purity, and assigned value? *
- Is the characterization performed using orthogonal, qualified analytical techniques? *
- Is a certificate of analysis with assigned potency/value on file for each standard? *
Working Standards
- Are secondary (working) standards qualified against the primary reference standard? *
- Is the qualification protocol and acceptance criteria for working standards defined? *
- Is a unique identifier and assigned value documented for each working standard lot? *
Storage and Handling
- Are reference standards stored under defined conditions to protect stability? *
- Are inventory, receipt, and usage records maintained with reconciliation? *
- Are handling precautions (desiccation, light protection, aliquoting) defined where needed?
Requalification and Lifecycle
- Are reference standards assigned expiry or requalification dates? *
- Is periodic requalification performed to confirm continued suitability? *
- Is a bridging study performed when transitioning between primary standard lots? *
- Are expired or invalidated standards controlled to prevent inadvertent use? *
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