Act Cap. N1 LFN, 2004 (formerly referred to as Decree 19 of 1993) mandates National Agency Food and Drug Administration and Control (NAFDAC) to regulate and control the importation, exportation, manufacture, advertisement, distribution, sales and use of food, drugs, cosmetics, medical devices, bottled water and chemicals (generally referred to as regulated products). 

Section 8, Subsection F of the structure of the Agency empowers the Laboratory for the analysis of regulated products.  

The Vaccines, Biologicals and Medical Devices Laboratory Services Directorate (VBM-LSD) is responsible for the physical, chemical, microbiological and serological testing of all vaccines, biologicals and medical devices including IVDs (In-vitro Diagnostics) submitted for routine, regulatory and investigations. These services are made in compliance with prescribed International Standards to ensure quality and safety of all products tested in the laboratory. VBM-LSD demonstrates its technical competence in Forty (40) testing scopes as it has sustained the ISO 17025:2017 Accreditation consistently for over five years. NAFDAC, of which the Laboratory is a part, operates its management system in line with Quality Management System standards evidenced by its ISO  9001:2015 Certification. 

The quality, safety and efficacy of vaccines and other biological alongside evaluation of Medical devices is carried out in five (5)laboratory units  namely Chemistry laboratory, Microbiology laboratory, Tissue culture laboratory, In-vivo laboratory and  Serology laboratory. 

The management of Laboratory samples is conducted on the Laboratory Information Management System(LIMS). 

Animal facility unit supports quality control activities with the provision of laboratory animals for testing. The Instrument Maintenance Unit(IMU)provides equipment maintenance services for the laboratory. 

FUNCTIONS

• Lot release function for  vaccines 
• Laboratory makes pronouncement on the quality, safety, efficacy and fitness for use of vaccines, biologicals, medical diagnostic devices and other medical devices after analysis / evaluation.  
• Participate in the cGMP Inspection of manufacturing Facilities. 
• Participate in vaccine clinical trial by testing for potency and safety of the product to be used for clinical trial. 
• The Laboratory performs confirmatory test on vaccines and other biologicals where there is suspicion of cold chain breakage etc. 
• Review dossiers, protocols, and other technical documents. 
• Capacity building of Corpers, interns and industrial Trainee Students. 
• Breeding and management of laboratory animals in the Animal Facility 
• Serves as the Secretariat for the National Advisory Committee on Vaccines and Biologicals(NACVB).