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In 2009 QCIL began its maiden production, commencing with its Antiretroviral dru g, Duovir-N, a fixed dose combination

of 3 drugs, Zidovudine, Lamivudine and Nev irapine and thereafter its ACT, Lumartem which consists of Artemether and Lumefa ntrine. The facility has an installed capacity of 6 million tablets per 24 hour shift and employs the latest state of the 1.0 INTRODUCTION QUALITY CHEMICAL INDUSTRIES LIMITED AN AFRICAN SOLUTION TO AN AFRICAN PROBLEM! Quality Chemicals Industries Ltd (QCIL) is joint venture between Quality Chemica l Industries Ltd, a local drug distribution company and Cipla Ltd, India, a lead ing Pharmaceutical manufacturer. The facility located in the suburbs of Kampala, Uganda was commissioned by H.E Yoweri Kaguta Museveni, the President of Uganda, on the 8th of October 2007 just a day before Uganda s Independence Day celebratio ns. It is estimated that over 90% of HIV/AIDS and malaria cases are in Africa. H owever, less than 1% of the drugs for these diseases are manufactured within Afr ica. Apart from making Africa more self reliant, the facility has been set to m itigate the TRIPS agreement which would prevent the Indian companies from sellin g their generic ARVs to the third world countries such as Uganda once it takes e ffect After its commissioning, the facility underwent an intensive validation phase ai med at ensuring that all equipments and systems that were installed met the requ ired standards of Good Manufacturing Practice. This took up the better time of 2 008 and culminated in receipt of various regulatory approvals from National Drug Authority (NDA), Drugs for neglected diseases(DNDI) and ICRC (International com mittee for Red cross), Geneva In 2009 QCIL began its maiden production, commencing with its Antiretroviral dru g, Duovir-N, a fixed dose combination of 3 drugs, Zidovudine, Lamivudine and Nev irapine and thereafter its ACT, Lumartem which consists of Artemether and Lumefa ntrine. The facility has an installed capacity of 6 million tablets per 24 hour shift and employs the latest state of the art technology in its manufacturing pr ocesses. Through QCIL, availability and access to ART and ACT s has been significa ntly improved especially through Uganda s public sector in addition to creating em ployment for the locals. In 2010 QCIL became among the first few Pharmaceutical industries in sub-Sahara Africa to receive approval from WHO for compliance with Good manufacturing pract ices (GMP) and to be included as an additional manufacturing site for Cipla s Duov ir-N and Lumartem products. The facility has also been audited and approved by t he Kenyan Pharmacy and poisons board and is awaiting the Tanzanian Food and Drug administration approval for compliance with cGMP expected early in 2010. All th is is a strong demonstration of QCIL s commitment to quality. The facility recently in 2010 also received approvals from NDA to manufacture it s Tenofovir based antiretroviral combination, Viraday, which once introduced wil l reduce the daily tablet intake to 1 pill a day down from 2 pills a day. QCIL h opes to introduce Viraday into the market in the near future coupled with establ ishing a bigger plant and putting up an active pharmaceutical ingredient facilit y. Currently, QCIL is manufacturing other ARV s like Duovir (which is a combination o f Zidovudine and Lamivudine), Efavir and Nevimune (composed of Nevirapine as an active ingredient). 1.1 VISION To become a center of excellence in manufacturing quality and affordable medicin es for Sub- Saharan Africa. 1.2 MISSION To assist in the provision of quality and affordable sustainable regional soluti ons to regional health conditions. 1.3 OBJECTIVES 1.3.1Broad Objectives: To obtain the practical skills and knowledge To appreciate the role of a chemist in a pharmaceutical industry and possible ch allenges faced while practicing in such a setting. 1.3.2 Specific objectives To ensure a steady supply of ARV S and ACT S in order to contain and roll back these

killer diseases. To expand accessibility to these life saving remedies by guranting affordability over the medium to long term To build rapid response and commercial distribution network that deliver ACT S and ARV S through the public health system.

1.4 SAFETY AND HEALTHY RULES AND REGULATIONS Always wear clean company uniform Smoking and drinking are prohibited within company premises Personal protective equipment must be worn where appropriate e.g. nose masks, ha nd gloves, safety gaggles etc. You must have a work permit for risky jobs Strictly follow the standard operating procedure No horse plays within the plant i.e. no practical jokes Does not abuse or misuse fire protection equipment? Do not use defective tools All material used are expensive and hazardous so make sure there is no spillage or wastage. Always disinfect your hands before entering the production area Observe personal and professional hygiene. Follow good housekeeping practices i.e. maintain a good organized and clean work ing area 1.5 THE COMPANY S ORGANIZATIONAL STRUCTURE

technology in its manufacturing

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