National Drug Quality Control Laboratory

The Quality Control Department performed analysis on various medicines and medical devices as follows;

Mandatory Testing of Products:
The laboratory carried out random testing of all anti-malarials, anti-TBs, generic ARVs, medical gloves, male latex condoms and some consignments of Public Health products particularly of Long Lasting Insecticidal Nets (LLINs) imported into Uganda.  The review of Batch Manufacturing records (BMRs), validation records and analysis of the initial 3 batches of new formulations for local manufacturers prior to marketing is a routine activity.

Analysis of samples using miniLabs
Since the acquisition of GPHF Minilabs by NDA under the Presidential Malaria Initiative (PMI) / USAID sponsored project, NDA commenced the sampling of anti-malarial medicine samples from the 7 NDA regions and testing the samples based at the NDA regional offices where the Minilabs are located.  NDA rolled out the use of Minilabs linked to post-marketing surveillance to sample and test various categories of medicines to include, but not limited to antibiotics, antiprotozoa, antifungal, analgesics, antiasthmatics, antidiabetics and antihelmintics.   Random sampling and testing of samples of various categories of medicines continues.  
According to the protocol for sampling & testing of medicine samples using Minilabs, activities are carried out at two levels:

Leve1: (activities done at the site of collection) - testing involves basic screening using Minilab monographs for:

• Visual inspection of  the dosage form and packaging, including labelling;
• Thin-layer chromatography (TLC) identification test;
• Thin Layer chromatography estimation of drug content; and,
• Disintegration test to predict the rate of release of medicine.

Level 2 (testing done at the NDQCL):  Involves testing a predetermined number of samples out of the total collected and tested at level 1 for verification purposes. Tests performed include: 1) appearance, 2) identification, 3) dissolution (where required) and 4) assay for content of active pharmaceutical ingredients (API), visible particle viewing of solutions for injections, uniformity of  weight, pH, and package seal integrity.
For the period of 1996 – 2009, medicines samples collected and tested are as shown in the table 1 below: 

 
 
 
Ministry of Health
Government of Uganda
World Health Orgnisation
Bill & Melinda Gates Foundation
Pharmaceutical Society of Uganda
USAID
UNCST
UNBS
NEMA
UIA