Laboratory Services
Operating under internationally recognised quality standards
About The Laboratory
The Botswana Medicines Regulatory Authority (BoMRA) Quality Control Laboratory provides independent scientific testing and evaluation of medicines, medical devices and related products to safeguard public health.
Operating under internationally recognised quality standards, the laboratory generates reliable analytical data to support regulatory decision-making, market surveillance, product quality assurance and public safety initiatives.
Responsibilities
Verification of the quality, safety and efficacy of medicines and related products.
Independent testing of pharmaceutical products against approved specifications.
Supporting regulatory decisions through scientifically valid and traceable results.
Post-market surveillance and screening of products available on the market.
Forensic identification and analytical support for law enforcement agencies.
Forensic identification and analytical support for law enforcement agencies.
Scope
Quality Control and Management
The BoMRA Quality Control Laboratory serves as a critical component of Botswana’s medicines regulatory system. Through advanced analytical testing and scientific expertise, the laboratory verifies that medicines and regulated products placed on the market meet established quality, safety and performance requirements.
Quality Management System
BoMRA Laboratory Services operates within a robust Quality Management System that complies with:
- ISO/IEC 17025:2017
- WHO Good Practices for Pharmaceutical Quality Control Laboratories (GPQCL)
This framework ensures technical competence, impartiality, consistency and confidence in laboratory results. Continuous improvement is maintained through regular audits, staff development programmes and participation in proficiency testing schemes.
Physicochemical Laboratory
Overview
The Physicochemical Laboratory is fully operational and performs analytical testing of pharmaceutical products to assess their chemical and physical characteristics. Testing activities verify product identity, strength, purity, performance and stability.
Testing Capabilities
The laboratory conducts a variety of pharmacopeial and regulatory tests, including:
Identification Testing
Assay Determination
Related Substances/Impurity Testing
Uniformity of Content
Dissolution Testing
Water Content Determination
pH Measurement
Disintegration Testing
Friability Testing
Loss on Drying Analysis
Analytical Equipment
Our modern instrumentation includes:
High-Performance Liquid Chromatography (HPLC)
Fourier Transform Infrared Spectroscopy (FTIR)
UV-Visible Spectrophotometers
Thin Layer Chromatography (TLC)
Karl Fischer Titrator
Dissolution Tester
Disintegration Tester
Friability Tester
Drying Ovens
pH Meters
Reference Standards and Methods
Testing is performed using internationally recognised standards and validated methodologies, including:
United States Pharmacopoeia (USP)
British Pharmacopoeia (BP)
Approved Manufacturer Methods where applicable
Physicochemical Laboratory
Overview
The Physicochemical Laboratory is fully operational and performs analytical testing of pharmaceutical products to assess their chemical and physical characteristics. Testing activities verify product identity, strength, purity, performance and stability.
Medical Devices Testing
BoMRA is expanding its laboratory services to include testing of selected medical devices, with an initial focus on male latex condoms and related products.
Planned testing capabilities include:
Dimensions and Length Verification
Tensile Strength Assessment
Bursting Pressure Testing
Air Leakage Testing
Water Leakage Testing
Electronic Pinhole Detection
Visual Defect Inspection
Lubrication Assessment
Package Integrity Evaluation
Labelling and Packaging Compliance Verification
Microbiology Services
Development and Expansion
The Microbiology Unit is currently under development and forms part of BoMRA’s long-term laboratory expansion programme. Current focus areas include theoretical vaccine lot-release screening and capacity building.
Future services are expected to include:
- Microbial Limit Testing
- Sterility Testing
- Environmental Monitoring
- Vaccine Quality Verification
- Microbiological Investigations
Field Screening and Surveillance
BoMRA employs rapid screening technologies to support post-market surveillance, border inspections and compliance monitoring activities.
Rapid Screening Technologies
TruScan Raman Spectrometer
The TruScan Raman Spectrometer enables rapid, non-destructive field screening of medicines to identify potential counterfeit, falsified or substandard products. Screening results help identify products that require further confirmatory laboratory testing.
Note: Screening results are preliminary and are not used as the sole basis for regulatory decisions. Confirmatory testing is conducted where necessary.
Forensic Analytical Services
BoMRA collaborates with the Botswana Police Forensic Department by providing scientific identification and analysis of medicines, pharmaceutical products and other substances submitted as part of criminal investigations.
These services strengthen national law enforcement efforts and support evidence-based investigations involving regulated products.
Cannabis and Cannabinoid Testing
As part of its strategic development initiatives, BoMRA is expanding laboratory capabilities to include Cannabis and Cannabinoid Testing.
Future analytical services will focus on:
- Potency Determination
- Cannabinoid Profiling
- Compound Identification
- Regulatory Compliance Testing
- Research Support Services
Need Laboratory Testing or Technical Information?
Our experts are available to provide guidance on laboratory services, regulatory testing.
Microbiology Services
Development and Expansion
The Microbiology Unit is currently under development and forms part of BoMRA’s long-term laboratory expansion programme. Current focus areas include theoretical vaccine lot-release screening and capacity building.
Future services are expected to include:
- Microbial Limit Testing
- Sterility Testing
- Environmental Monitoring
- Vaccine Quality Verification
- Microbiological Investigations