The BoMRA laboratory services are found under the Licensing and Enforcement department of BoMRA.The Laboratory is currently housed in Central Medical Stores facility in Gaborone West Industrial. The laboratory consists of the Physicochemical, Microbiology, and Medical devices sections.The Microbiology section is currently not functional.
The unit is responsible for the analysis of medicines and related substances as well as medical devices placed on the market to determine their fitness for purpose and verify manufacturer claims on their quality, efficacy, and safety. Timely testing and reporting of results as well as results validity are important outputs for a successful laboratory operation
The laboratory achieves this through the implementation of a laboratory quality management system based on the principles of ISO 17025;2017 and the WHO prequalification guidelines and led by a laboratory manager supervising four analysts and one lab assistant in the physicochemical and medical devices sections of the laboratory.
The laboratory encompasses essentially two types of activity: — compliance testing of finished pharmaceutical products employing “official” methods including pharmacopeial methods, validated analytical procedures provided by the manufacturer; and — testing of suspicious, counterfeit substances or products, submitted for examination by enforcement medicine inspectors, customs or police.
The laboratory performs its test based on Pharmacopeial prescribed methods which are the US Pharmacopeia, British pharmacopoeia, and The International Pharmacopeia.
Successfully implemented the USP Ghana Project
Achieved 72 % WHO GBT ML 3
65 per cent of PMS 1st round samples have been tested
Successfully participated in Proficiency testing conducted by USP Ghana through AMQF Network
To achieve WHO Maturity level 3 by 31 March 2021.
To achieve ISO 17025 Accreditation readiness (75 %) by 31 March 2021.
% Level of readiness for accreditation (5 methods).
Long procurement processes and procedures
Long delivery time for equipment (some equipment are made per order), consumables, and reagents
Unavailability of maintenance and service providers locally
Difficulty to get consultants and service providers on-site due to COVID-19 travel restrictions due