[E-drug nous informe que le rapport d'inspection de l'industrie
pharmaceutique "Quality Chemical Industries Ltd" de Kampala (Ouganda) est
disponible sur le site web de l'OMS. Cette industrie respecte les Bonne
Pratiques de fabrication.
http://apps.who.int/prequal/WHOPIR/WHOPIR_QCIL25-28January2010.pdf
Mais elle ne fait pas encore partie des laboratoires préqualifiés par l'OMS
voir également la clarification posté le 12 Mars 2010 sur le site web de WHO Prequalification of Medicines Programme concernant ce laboratoire
http://apps.who.int/prequal/info_press/pq_news_12March2010_UGA_Manufacturer.pdf
"As indicated by the posting1 of the WHO Public Inspection Report relating
to the manufacture of finished pharmaceutical products by Quality Chemical
Industries Ltd (QCIL) of Luzira, Uganda, QCIL was inspected in January 2010
and found to comply with WHO good manufacturing practice (GMP). This does
not constitute prequalification by WHO of the products manufactured by QCIL.
The inspection followed the receipt of a variation application from Cipla
Ltd, to include QCIL's site at Luzira as an additional manufacturing site
for one of its antiretroviral products. This particular product, currently
manufactured in India, has already been prequalified by WHO.
Prequalification of a product has two major components: evaluation of a
dossier containing product-related information and inspection of the
manufacturer for compliance with GMP. The variation application to add
QCIL's site at Luzira is currently under assessment by WHO.
A variation is a change to the prequalified product dossier. Any such
changes (variations) may involve administrative and/or more substantial
changes (that may impact on safety, quality and efficacy) that are subject o
approval by WHO."
CB]