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1.0 INTRODUCTION QUALITY CHEMICAL INDUSTRIES LIMITED AN AFRICAN SOLUTION TO AN AFRICAN PROBLEM!

Quality Chemicals Industries Ltd (QCIL) is joint venture between Quality Chemical Industries Ltd, a local drug distribution company and Cipla Ltd, India, a leading 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 Ugandas Independence Day celebrations. It is estimated that over 90% of HIV/AIDS and malaria cases are in Africa. However, less than 1% of the drugs for these diseases are manufactured within Africa. Apart from making Africa more self reliant, the facility has been set to mitigate the TRIPS agreement which would prevent the Indian companies from selling their generic ARVs to the third world countries such as Uganda once it takes effect After its commissioning, the facility underwent an intensive validation phase aimed at ensuring that all equipments and systems that were installed met the required standards of Good Manufacturing Practice. This took up the better time of 2008 and culminated in receipt of various regulatory approvals from National Drug Authority (NDA), Drugs for neglected diseases(DNDI) and ICRC (International committee for Red cross), Geneva In 2009 QCIL began its maiden production, commencing with its Antiretroviral drug, Duovir-N, a fixed dose combination of 3 drugs, Zidovudine, Lamivudine and Nevirapine and thereafter its ACT, Lumartem which consists of Artemether and Lumefantrine. 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

processes. Through QCIL, availability and access to ART and ACTs has been significantly improved especially through Ugandas public sector in addition to creating employment 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 practices (GMP) and to be included as an additional manufacturing site for Ciplas Duovir-N and Lumartem products. The facility has also been audited and approved by the Kenyan Pharmacy and poisons board and is awaiting the Tanzanian Food and Drug administration approval for compliance with cGMP expected early in 2010. All this is a strong demonstration of QCILs commitment to quality. The facility recently in 2010 also received approvals from NDA to manufacture its Tenofovir based antiretroviral combination, Viraday, which once introduced will reduce the daily tablet intake to 1 pill a day down from 2 pills a day. QCIL hopes to introduce Viraday into the market in the near future coupled with establishing a bigger plant and putting up an active pharmaceutical ingredient facility. Currently, QCIL is manufacturing other ARVs like Duovir (which is a combination of 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 medicines for Sub- Saharan Africa.

1.2 MISSION

To assist in the provision of quality and affordable sustainable regional solutions 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 challenges faced while practicing in such a setting. 1.3.2 Specific objectives To ensure a steady supply of ARVS and ACTS 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 ACTS and ARVS 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, hand 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 working area

1.5 THE COMPANYS ORGANIZATIONAL STRUCTURE