Mandate of the Directorate

The National Drug Quality Control Laboratory is a World Health Organization (WHO) prequalified Laboratory with international ISO 17025 accreditation and it is well equipped with robust equipment, qualified personnel and has a well-established and maintained Quality Management System

The laboratory is mandated to analyze different categories of medicines, medical devices and Public health products, and samples are obtained from pre market, post shipment and Post Market Surveillance.

The laboratory derives its mandate from the NDP/A act:

Section 35;

The authority may scientifically examine any drug for the purposes of ascertaining efficacy and quality of that drug

Section 5 g;

Encourage research and development of herbal medicines

Major Goals of NDQCL

  • To conduct quality control testing of drug samples and provide accurate and precise results.
  • To carry out laboratory processes and activities in accordance with the WHO GPCL and ISO/IEC 17025 standards
  • To ensure that quality assurance mechanisms are adhered to.
  • To meet the objectives of National Drug Authority.
  • To ensure customer satisfaction.
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Word from the Director

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The National Drug Quality Control Laboratory, housed by the Directorate of Laboratory Services is both ISO 17025:2017 and WHO qualified.

 

Medicines Unit

This is responsible for performing physicochemical analysis of medicines (allopathic and herbal),food fortificant, acaricides, and public health chemicals. This laboratory is WHO accredited and the scope of accreditation includes;

  • Assay by liquid chromatography, gas chromatography , spectrophotometry, Titration
  • Dissolution
  • PH
  • Loss On Drying
  • Moisture determination by Karl Fisher
  • Uniformity of Dosage
  • Identification by FTIR and TLC
  • Polarimetry

The laboratory is in the final stages of equipping a state of the art microbiology Laboratory process of building capacity for performing Microbiological Analysis

Medical devices unit

This is accredited to the ISO/IEC 17025:2005; the scope of accreditation incudes;

  • Male latex condoms
  • Female Condoms
  • Gloves(Surgical and Examination)

The laboratory also tests syringes and needles, sutures, and is currently building capacity to test catheters, cannulas, RDT kits

Laboratory Quality Management Unit

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Condom Air Burst equipment: Tests for air pressure and volume of the latex condoms.
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Water leak condom tester: Detects holes; ensuring quality of condoms on the market.
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Karl fisher/Auto titrator medicine testing equipment.
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Dissolution testers used for testing the amount of medicine that dissolves in the body
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High performance liquid chromatographic systems (HPLCs). NDA has state of the art fully automated equipment and technical expertise with vast years of experience in the analytical area, dedicated to doing routine testing of all medicines in Uganda
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Fourier transform infrared spectrometer: Used for identification of medicines.
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Gloves/ Condom visual leak tester: used to ensure that medical gloves are free from holes.
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Sample preparation area in the medicine testing Laboratory
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Gas chromatography equipment, used for testing insecticides in the LLINs and acaricides.
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MPs on the Health Committee visited National Drug Authority's Quality Control Laboratory. The visit that followed NDA's appearance before the committee in February and March, was part of their efforts to understand the functions and operations of the Authority.
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NDA acquired and successfully installed a state of the art High Performance Thin Layer Chromatograph (HPTLC); a high precision analytical instrument that will be used in testing of herbal medicines before they are approved for public distribution and consumption
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State of the art High Performance Thin Layer Chromatograph (HPTLC); a high precision analytical instrument that will be used in testing of herbal medicines before they are approved for public distribution and consumption