The Vaccines, Biologicals, and Medical Devices Laboratory Services Directorate (VBMLSD) of the National Agency for Food and Drug Administration and Control (NAFDAC) is the official Quality control laboratory for vaccines, biologicals, and Medical Devices, including IVDs.
NAFDAC is the only National Regulatory Authority (NRA) with an in-house laboratory for Quality Control of vaccines and Biologicals in Sub-Saharan Africa
VBM-LSD is responsible for testing and determining the disposition of all human and veterinary vaccines, biologicals, and medical devices submitted for regulatory or investigative purposes. The laboratory aims to provide reliable, accurate analytical services in compliance with WHO GPPQCL and ISO 17025 standards.
The laboratory operates a quality management system and holds ISO 17025:2017 accreditation for 40 specific test scopes covering vaccines, biologicals, and medical devices.
VBMLSD is an affiliate member of the WHO-National Control Laboratory Network for Biologicals (WHO-NNB).
Regulatory Framework
The regulatory framework of the laboratory rests on the Regulation on Lot Release, the guideline on Chemistry, Manufacturing and Controls (CMC) document, and approved SOPs
The Lot release function is a key responsibility of Vaccines, Biologicals, and Medical Devices Laboratory Services (VBMLSD). Each vaccine lot is independently tested for conformance to its intended specifications. The laboratory issues Lot Release Certificates for imported vaccines to ensure that only high-quality products, essential for preventing and controlling infectious disease outbreaks, are available for use in Nigeria.
VBMLSD comprises several laboratory units, including Microbiology, Chemistry, Tissue Culture, In-vivo, and Medical Devices & Serology. These units conduct a broad range of tests, such as Bacterial Endotoxin, ELISA, Virus Titration, Thermo-stability, potency, and sterility, using applicable pharmacopeia or validated manufacturer-recommended methods to ensure product quality.
The laboratory is equipped with state-of-the-art instrumentation to perform regulatory functions and quality control activities, including conventional and real-time PCR machines, ELISA readers, HPLC systems, and UV/Vis spectrophotometers.
The facility is staffed by highly qualified, competent personnel with extensive domestic and international training and years of experience in various disciplines, ensuring rigorous quality control testing for biological products, including vaccines.
Laboratory Building
The facility is a 2-storey ultra-modern cGMP-compliant laboratory at Oshodi, Lagos state. The Laboratory complex would have different classes of clean rooms based on the quality control activities to be carried out there. The Cleanroom Considerations are modular panels, Airlocks, HVAC system, and Environmental monitoring system.
