The NDQCL is the quality control and assurance department of National Drug Authority.
Historical Background:
The testing of medicine samples begun in 1994 at the Government Analytical Laboratory, Wandegeya then later samples were tested at the Kampala Pharmaceutical Industries (1996) Ltd. (KPI).
In 1997 NDA established a physico-chemical mini-laboratory at the department of Pharmacy - Makerere University which was used to test medicines (1998 -1999). The mini-lab is currently used by the pharmacy department to train pharmacy students.
In 1997, in addition to routine testing of medicine samples, the QC & A department carried out a survey of all quinine Mixtures that were available on the market. This resulted into standardization of the dosage requirement of quinine syrup produced by local manufacturers of Uganda.
In November 1999 the NDQCL building at Mulago Hill was officially handed over by the Government of Uganda (GoU) to NDA to reinforce the capacity to test medicine samples. Testing of medicine samples began at the new laboratory in February 2000.
Purpose:
To ensure that all pharmaceutical products on the market, whether locally manufactured or imported, are of good quality and are therefore safe for their intended use.
Our Services:
NDA has an obligation to carry out testing of medicine and medical device samples according to international standards (BP, USP, Int.P, ASTM, ISO 4074) as per the NDA ACT of 2006. The NDQCL has therefore set up a quality system to ensure that all activities are done as per Good laboratory Practice (GLP). The major service offered by the NDQCL is testing of drugs, medical devices and other health care products following approved standard operating procedures in line with international standards.
Main Activities:
Analysis of medicine samples collected from ports of entry into Uganda, hospitals, Pharmacies, drug shops, and other drug outlets.
Mandatory post-shipment testing of male latex condoms & medical glove samples from ports of entry into Uganda.
Testing of insecticides especially Long Lasting Insecticidal Nets (LLINs) samples from the ports of entry, pharmacies and drug shops.
Participate in cGMP inspections of local and foreign drug manufacturing facilities.
Mandatory testing of initial 3 batches of each new formulation, review of Batch Manufacturing records (BMRs) and validation records from local manufacturers before authorization for commercialization.
Participates in dossier evaluation.
Our Workforce:
1 Head of Department
2 Senior Drug Analysts
6 Drug Analysts
2 Laboratory technicians
2 Laboratory Assistants
10 Medical Device Quality Analysts
Administrative staff - 4 persons
Major equipment at the laboratory:
High Performance Liquid Chromatograms
UV-Vis Spectrophotometers
Fourier Transform Infrared Spectrophotometer (FTIR)
Gas Chromatography (GC)
Dissolution testing apparatus
Five-decimal place analytical balances
Three-decimal precision balances
Complete Fume hood units
IR- Drier- Programmable
Flame Photometer
Auto titrimeter
A set of Condom testing equipment
Water leak test device for gloves.
pH/Conductivity meters
Thin layer Chromatography (TLC)
Achievements:
The quality of medicines, condoms and gloves continues to improve from year to year and is being regularly monitored to ensure compliance.
Local pharmaceutical companies have benefited from the various training workshops conducted at the laboratory.
Several projects have supported the quality control activities of the NDQCL in terms of laboratory equipment and training.
Six (6) GPHF Mini-lab kits have been acquired and are used to test medicines samples at the 7 NDA regional offices in Uganda. This has complemented the quality control activities done at the NDQCL.
Future plans:
Install a wide area network (WAN) Laboratory Information Management System (LIMS).
Extension of the NDQCL building to create space for more laboratory activities.
Work towards the WHO pre-qualification of NDQCL and ISO/IEC 17025.
Establish a LIMS System to ease data analysis. |
