About the Directorate

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.

What NDQCL tests

  • All human medicines including herbal medicines
  • Insecticide treated mosquito nets
  • Hand sanitizers (Liquids and gels)
  • Veterinary medicines like acaricides
  • Medical devices such as male and female condoms, surgical sutures, latex examination gloves, syringes and needles, Rapid Diagnostic Tests, surgical face masks.

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

For any pharmaceutical analysis and quality control inquiries, Please send an email to ndaqc@nda.or.ug

Key Activities of NDQCL

  • Conducting quality assessment through laboratory analysis of medicines (human and veterinary), medical devices, surgical instruments and public health products while subsequently reporting accurate and precise results in a timely manner.
  • Field testing of regulated products using screening techniques such as NIR spectrometry, Raman spectrometry and TLC techniques.
  • Generating scientific evidence and reports on the quality and safety status of the regulated products in order to inform and facilitate regulatory decision making.
  • Providing technical support to local manufacturers and building their capacity in matters pertaining to quality control of regulated products through on site and off site training and laboratory assessments.
  • Conducting investigations into the quality and safety status of regulated products for purposes of pursing legal or regulatory action.

News / Events

Accreditation

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

 

Services

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

Service Delivery Timelines

REGULATORY AREAACTIONTIMELINE
Laboratory testingTest results from mandatory testing after sampling (Medicine)-PoE.48days
Test results from mandatory testing after sampling (Medical Devices).30days
Test results from client requests after acceptance by the lab (All Products).45days
Test results for pre-market samples (Domestic Manufacturers).60days
Test results for Public Health Products (LLINs, Face Masks, Hand Sanitizers and other) samples.45days
Test results for post-market surveillance (Medicines).48days

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    News and Events

    Staff from the different directorates undergoing training on sampling and testing of condoms sponsored by UNFPA. NDQCL takes pride in assuring personnel development and continuous improvement in the operations of NDA as we strive to achieve our mandate.

    Demonstration on one of the techniques used for assessing the quality of male latex condoms by One of the staff members at DLS during the ISO 17025 audit.The audit is meant to assess the Laboratory compliance to the requirements of the ISO standard

    Demonstration on one of the techniques used for assessing the quality of male latex condoms by One of the staff members at DLS during the ISO 17025 audit.The audit was meant to assess the Laboratory compliance to the requirements of the ISO standard