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생명과학 eQMS 14개 항목

Reference Standard Management Checklist

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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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