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14Annual Report on Lymphatic Filariasis 2003Chapter 1 Progress of the Global Programme to Eliminate Lymphatic Filariasis• LF experts from around the world having informationon manufacturers of DEC;• organizations such as the International Generic PharmaceuticalAlliance, British Generic Association, andthe online network E-Drug.In addition, a search was launched through the Internetand through advertisements placed in internationaljournals and pharmaceutical guides and compendia.In November 1999, an inventory of DEC manufacturerswas prepared. The inventory included only manufacturersthat supplied information on quality assurance intheir manufacturing sites. Because of the geographicaldistribution of the disease, many commercial manufacturersof DEC tablets were identified in the developingworld, of which approximately half were in India.In 2003, WHO procured 121 million DEC tablets whichwere supplied to 22 endemic countries.Developing a modern assay for DECIn March 2000, GPELF organized an informal consultationto secure a consensus on appropriate standards andguidelines proposed for the DEC active pharmaceuticalingredient (API) and tablets and to discuss currentlyavailable assay methods. Participants recommendedthat WHO develop a modern stability-indicating assayfor DEC that meets current standards, including dissolution.A high-pressure liquid chromatography (HPLC)analytical method was developed in Switzerland andvalidated by independent laboratories in Germany,India and Sri Lanka. The United States Pharmacopoeiaand the Indian Pharmacopoeia have adopted this newmodern stability-indicating method for DEC.DEC prequalification processOnly manufacturers are eligible for prequalificationwithin the DEC project. Before an on-site inspectioncan take place, the project team requires that an independentanalytical laboratory evaluate DEC, and themanufacturer is requested to complete the WHO InformationQuestionnaire for Prospective Suppliers of PharmaceuticalProducts and supply additional technicalinformation. The inspection team includes WHO staffand former senior members of a European regulatoryagency (signatory of the Pharmaceutical InspectionCooperation Scheme), a multinational pharmaceuticalcompany, and a pharmaceutical manufacturing facilityin Australia.The manufacturer is requested to provide a copy of themost recent batch record for manufacturing and packaging,and information on stability studies, sources ofreference substances, active pharmaceutical ingredientsand all other materials used in manufacture. Additionally,the company must conduct the stability tests of DECaccording to the WHO Stability Guidelines for Zone IV(hot and humid conditions) and International Conferenceof Harmonization Guidelines for evaluation of stability ofpharmaceuticals in Zone IV (Quality Topic Q1F). Theteam requests national or state regulatory authorities tonominate inspectors to accompany the inspection team.It discusses the DEC project with the regulatory authorities,inspectors, and the minister of health for the state orcountry. The inspection team uses WHO guidelines duringthe inspection as a general guide to GMP.Prequalification of two DEC manufacturersA manufacturer that has an acceptable complianceprofile is confirmed as a prequalified DEC provider.Prequalification is valid for two years. After this timemanufacturers should be re-inspected and re-qualified,preferably by or with the assistance of the national drugregulatory authority, through an evaluation of recentdocumentation and on-site inspection.Although a number of manufacturers have been identifiedby the DEC project, not all were compliant on variouscriteria and tests. From November 2002, the two prequalifiedDEC tablet manufacturers are Panacea Biotech, NewDelhi, India, and Unichem Laboratories, Goa, India.There is only one prequalified DEC API manufacturer:Syntholab Chemicals and Research, Mumbai, India.WHO purchases DEC tablets from prequalified manufacturersonly. Country programmes are also stronglyencouraged to use prequalified DEC manufacturers fortheir purchases.Developing a quality surveillance systemGPELF is currently developing an ongoing system tomonitor the quality of purchased DEC. Randomized collectionof samples from each of the manufacturers is
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
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