Share

Standardization in the service of new distribution rules of health products under controlled temperature.

La normalisation au service des nouvelles règles de distribution des produits de santé sous température dirigée.

Author(s) : GUILPART J., MAHE C.

Type of article: Article

Summary

European and French regulations have changed over several months. After the modifications of the European directive 2001/83/EC published on November 6, 2001 on community code relating to medicinal products for human use, good distribution European practices (GDP) of medicinal products has been changed. They will be published soon. The cold chain issue is taken into account and reinforced. Therafter French good distribution practices should be adapted. Standardization can be an important tool to implement these new good distribution practices of medicine products. However actually only a few standards about the cold chain tools of medicinal products or about the cold chain management system are available. This article analyzes the regulatory evolution imposing new organizational or technical means and presents current cold chain standards and the standardization orientations about cold chain of medicinal products. It presents the trade's point of view on the current standard utilization and on their standardization needs.

Details

  • Original title: La normalisation au service des nouvelles règles de distribution des produits de santé sous température dirigée.
  • Record ID : 30008566
  • Languages: French
  • Source: Revue générale du Froid & du Conditionnement d'air - vol. 102 - n. 1124
  • Publication date: 2012/06

Links


See other articles in this issue (3)
See the source

Indexing