Directorate of Laboratory Services - National Drug Authority

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.

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.

News / Events

A glance at NDA performance FY 2019/2020: NDA Quality Control Laboratory

December 17, 2020

NDA’s Quality Control Laboratory is prequalified by World Health Organization…

Word from the Director

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

Reports

Image Gallery

NDA-Picture5 — Condom Air Burst equipment: Tests for air pressure and volume of the latex condoms.

NDA-Picture6 — Water leak condom tester: Detects holes; ensuring quality of condoms on the market.

NDA-Picture13 — Karl fisher/Auto titrator medicine testing equipment.

NDA-Picture10 — Dissolution testers used for testing the amount of medicine that dissolves in the body

NDA-Picture11 — 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

NDA-Picture12 — Fourier transform infrared spectrometer: Used for identification of medicines.

NDA-Picture7 — Gloves/ Condom visual leak tester: used to ensure that medical gloves are free from holes.

NDA-h — Sample preparation area in the medicine testing Laboratory

NDA-Picture9 — Gas chromatography equipment, used for testing insecticides in the LLINs and acaricides.

NDA-mp1 — 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.

NDA-new1 — 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

new2 — 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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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 was meant to assess the Laboratory compliance to the requirements of the ISO standard