News about GMP/cGMP

06.12.2019

EC: Eight technical guidelines for individual identifiers (UDIs)

On 4 December 2019, the European Commission published eight documents containing technical specifications for unique device identifiers (UDIs). 

Four documents of

  • GS1 (Global Standards One)
  • HIBCC (Health Industry Business Communications Council)
  • ICCBBA (International Council for Commonality in Blood Banking Automation) und
  • IFA (Informationsstelle für Arzneispezialitäten)

deal with Basic UDI-DI. These are required for the upcoming Eudamed database and consist of an 18-character string reflecting the manufacturing facility, the type of product and the product description code.

The four other documents deal with UDI human readable interpretation (HRI) formats. The information includes UDI-DI, lot number, expiration date, serial number and manufacturing date.


Source:

EC: Technical Guidance for UDIs

 



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