title: Implementation of 350-2500 nm diffuse reflectance spectroscopy and High-Performance Thin-Layer Chromatography to rapidly assess manufacturing consistency and quality of cotrimoxazole tablets in Tanzania.
abstract: OBJECTIVE
  To assess the quality of cotrimoxazole tablets produced by a Tanzanian manufacturer by a newly instituted quality assurance programme.
  
  
  METHODS
  Tablets underwent a diffuse reflectance spectroscopy procedure with periodic quality assessment confirmation by assay and dissolution testing using validated HPTLC techniques (including weight variation and disintegration evaluations).
  
  
  RESULTS
  Based on results from the primary test methods, the first group of product was <80% compliant, whereas subsequent groups reached >99% compliance.
  
  
  CONCLUSIONS
  This approach provides a model for rapidly assuring product quality of future procurements of other products that is more cost-effective than traditional pharmaceutical testing techniques.
authors.affiliation: Pharm R&D Lab, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
authors.forename: Eliangiringa
authors.initials: E
authors.lastname: Kaale
authors.affiliation: United States Agency for International Development, Washington, DC, USA.
authors.forename: Samuel M
authors.initials: SM
authors.lastname: Hope
authors.affiliation: Product Quality and Compliance, FHI 360, Durham, NC, USA.
authors.forename: David
authors.initials: D
authors.lastname: Jenkins
authors.affiliation: Supply Chain Management System, Arlington, VA, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Layloff
keywords: 
  USAID
  ; Asociación para la Gestión de la Cadena de Suministro; Cromatografía de Capa Fina de alto rendimiento; Cromatografía de Líquidos de Alto rendimiento; High-Performance Liquid Chromatography; High-Performance Thin-Layer Chromatography; Partnership for Supply Chain Management; Sistema de Gestión de la Cadena de Suministro; Supply Chain Management System; chromatographie liquide haute performance; chromatographie sur couche mince haute performance; infrarouge proche; infrarrojo cercano; near-infrared; partenariat pour la gestion de la chaîne d'approvisionnement; système de gestion de la chaîne d'approvisionnement