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(2012; 4 pages)
The WHO Prequalification of Medicines Programme (PQP) was launched in 2001, in partnership with UNAIDS, UNICEF and UNFPA, with support from the World Bank. Its focus was evaluation of medicines for treating HIV/AIDS, malaria and tuberculosis (TB). Products in other therapeutic categories are now also evaluated.
The Programme reviews product dossiers, including data and information on safety, efficacy and quality, and inspects manufacturing sites, to assess compliance with good manufacturing practices (GMP). It also inspects clinical sites, including contract research organizations (CROs), to verify compliance with good clinical practice (GCP) and good laboratory practices (GLP), with respect to bioequivalence studies. It also prequalifies medicines quality control laboratories (QCLs).
For further information on medicines and QCL prequalification go to: http://www.who.int/prequal