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생명과학 eQMS 13개 항목

DSCSA Serialization and Traceability Checklist

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Confirms that a manufacturer or repackager meets Drug Supply Chain Security Act requirements for product identification, serialization, verification, and interoperable electronic tracing at the package level. Use to audit DSCSA readiness.

DSCSA (21 USC 360eee)FDA DSCSA GuidanceGS1 Standards

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Product Identification

  • Does each saleable unit and homogeneous case bear a product identifier with NDC, serial number, lot, and expiration? *
  • Is the product identifier encoded in both human-readable and 2D data matrix (GS1) form? *
  • Are serial numbers unique, randomized where required, and managed to prevent duplication? *

Aggregation and Data

  • Is parent-child aggregation (unit to case to pallet) captured to enable inference-free tracing? *
  • Are transaction information and transaction statements captured in interoperable electronic form? *
  • Are EPCIS-based data exchanges established with trading partners?

Verification and Returns

  • Can the product identifier be verified upon request within the required timeframe? *
  • Are saleable returns verified against the product identifier before resale? *
  • Are suspect and illegitimate product investigation and quarantine procedures in place? *
  • Are notifications to FDA and trading partners for illegitimate product defined? *

Trading Partners and Records

  • Are all trading partners verified as authorized (licensed/registered)? *
  • Are transaction records retained for at least 6 years? *
  • Is the serialization system validated and secured against data integrity risks? *

DSCSA Serialization and Traceability Checklist 체크리스트 전체 다운로드

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