US FDA: Twee nieuwe Track and Trace richtsnoeren

The FDA has released two new guidances for interpreting track and trace requirements: Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry, and Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act.
The guidance document on data and documentation elaborates on the standards for the interoperable exchange of transaction information, transaction history, and transaction statements required by section 582 of the Federal Food, Drug, and Cosmetic Act. The other document defines suspect product and illegitimate product as they appear in section 581 (Serialization Countdown, 5 maart 2018).
Klik hier om het volledige nieuwsbericht te lezen.
Klik hier om het conceptrichtsnoer Standardization of Data and Documentation Practices for Product Tracing te downloaden (170 kB).
Klik hier om het conceptrichtsnoer Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act te downloaden(282 kB).

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