[Le service de pré-qualification de l'OMS encourage maintenant les
producteurs de matières premières à se soumettre aux procédures de son
service qui accrédite le site de production de la matière première. Deux
couples matières première/producteurs ont reçu leur accréditation :
* Artemether manufactured by Mangalam Drugs and Organics Limited
* Lumefantrine manufactured by Mangalam Drugs and Organics Limited
Plus d'infos sur le site.CB]
Prequalification Update - 19 April 2011
http://apps.who.int/prequal/
Second Active Pharmaceutical Ingredient (API) Prequalified
Artemether manufactured by Mangalam Drugs and Organics Limited, is the
second active pharmaceutical ingredient (API) to be prequalified by the WHO
Prequalification of Medicines Programme (PQP) under its API prequalification
procedure, launched in October 2010.
Lumefantrine manufactured by Mangalam Drugs and Organics Limited, was the
first active pharmaceutical ingredient (API) to be prequalified by the WHO
Prequalification of Medicines Programme (PQP). (See PQ Update of 12 April
2011)
Good-quality APIs are vital to the production of good-quality medicines.
WHO's prequalification of APIs will facilitate production of quality
medicines by identifying such APIs for manufacturers of finished
pharmaceutical products.
API prequalification consists of a comprehensive evaluation procedure that
has two components: assessment of the API master file (APIMF) to verify
compliance with WHO norms and standards, and evaluation of the sites of API
manufacture to verify compliance with WHO GMP requirements.
Related Links:
WHO List of Prequalified Active Pharmaceutical Ingredients
Second Invitation for Expression of Interest (EOI) recently issued for
APIs seeking prequalification
Further details relating to the Prequalification of API procedure