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ライフサイエンスeQMS 14項目

Reference Standard Management Checklist

このチェックリストは英語版です。

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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