Global Programme to Eliminate Lymphatic Filariasis ... - libdoc.who.int

15handled by an independent company before laboratorytesting is carried out to determine whether DEC meetsinternationally recognized standards. WHO encouragesadoption of this ongoing quality surveillance system innational programmes.Savings linked to bulk purchaseProcurement officials know that increasing the numberof tablets purchased normally reduces the price per unit.Experience in WHO has also shown that consolidatingorders for many countries based on the projections ofan annual global forecast reduces the price even further.Within the project, orders were consolidated for severalcountries and, using funds provided to WHO by donors,the price obtained per 1000 DEC tablets was 30–45%lower than that paid in 1999. This process demonstratesthat a centralized process for purchasing a large numberof tablets for several countries lowers the cost. The moneysaved enables additional amounts of DEC tablets to be purchasedwhile ensuring the highest standards of quality.Capacity-buildingGPELF has built capacity in LF-endemic countriesthrough the provision of training and expertise whileimproving compliance with GMP and good laboratorypractices (GLP). Through on-site inspections, both themanufacturer and national regulatory personnel havethe opportunity to learn, gain experience, and improveproduction procedures and quality assurance systems.During an inspection, the team explains why a procedureis not acceptable or acknowledges compliance andencourages participants to use the exercise as a learningexperience, thereby contributing to expanding understandingand improving application of internationallyrecognized standards.The DEC project collaborates with manufacturers toensure that they implement corrective action and maintainGMP and GLP during the entire period of validityof the prequalification status for DEC. All improvementsthat manufacturers make are to the benefit of the LFelimination initiative. The manufacturer is provided witha report listing the observations made during the inspectionand a summary of any deficiencies in GMP or GLP.Since initiation of the project in August 1997, WHO hasinvested technical and human resources in order to:• develop and validate new analytical methods for DEC;• perform dissolution tests of DEC tablets;• test DEC API and DEC tablets in an independent laboratory;• conduct various on-site inspections;• provide necessary technical assistance;• follow up the above activities.The benefits gained are substantial. The initial investmentis designed to give long-term benefit by ensuringthat national programmes to eliminate LF administerquality DEC tablets in 60 of the 83 endemic countriesduring the 15 years of MDA.Successful resultsThe prequalification process has ensured that DEC tabletsand APIs have been manufactured in compliancewith international standards. In this way, supplies ofDEC have been made available for LF elimination activitiesat a low cost.The prequalification process has functioned very successfully.The project must now ensure that manufacturingis sustained and sufficient quantities of qualityDEC are provided to meet the long-term requirementsof the programme. In order to meet the global forecast,bulk purchasing through an international competitivebid mechanism must continue to be strengthened toenable cost reduction and effect significant savings.Annual Report on Lymphatic Filariasis 2003Chapter 1 Progress of the Global Programme to Eliminate Lymphatic Filariasis