About Vaccines, Biologicals And Medical Devices Laboratory Services Directorate

HISTORY

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.

LABORATORY SERVICES DIRECTORATE

The Laboratory Services (LS) Directorate is the arm of the Agency that investigates and pronounces on the quality, safety, efficacy and wholesomeness of regulated products both imported and locally manufactured.

• Conducts appropriate tests and ensure compliance with standard specifications designated and approved by the Council for the effective control of the quality of food, drugs and other regulated products and their production processes as well as their production processes in factories and other establishments.
• Establishes and maintains relevant laboratories in strategic areas of Nigeria as may be necessary for the performance of its functions.
• Pronouncing the quality and safety of food, drugs and other regulated products after appropriate analysis.
• Undertaking of laboratory work on the storage, adulteration, distribution and rational use of food, drug, and other regulated products.
• Analytical investigation into Enforcement/task force samples for sanctions and prosecutions
• Develop analytical method for analyzing food, drugs and other regulated products and
• Serve as reference Laboratory for other Governmental Agencies eg Nigeria Customs Service by analyzing samples for tariff classifications, NDLEA to identify narcotic drugs and Psychotropic substances, Nigeria Police Force for analysis of forensic samples.

NAFDAC in its effort to achieve its mandate as the National Regulatory Authority (NRA) for vaccines performs the six critical WHO REQUIREMENTS for regulation of Vaccines.

The six critical functions are as follows: –

1)     Licensing (Registration) of vaccines and other biologics – Refer to Regulatory and Registration Directorate.

2)     Inspection – Refer to Drug Evaluation and Research Directorate

3)     Laboratories assess (Laboratory Services)

4)     Lot Release (Laboratory Services)

5)     Post Marketing Surveillance -Pharmaco Vigilance & Post-Marketing Survey Directorate.

6)     Clinical trial authorization –Refer to Regulatory and Registration Directorate.

The laboratory was made a directorate on the 5^th August 2022.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.

The Laboratory has ISO 17025:2017 accreditation for forty (40) test scopes: See attached link

LABORATORY PROFILE

The quality, safety and efficacy of vaccines and other biological alongside evaluation of Medical devices is the primary responsibility of (VBM-LSD) and this it achieves with ten units closely working together. These units are Chemistry laboratory, Microbiology laboratory, Tissue culture laboratory, In-vivo laboratory, Serology laboratory, Animal facility unit, Instrument maintenance Unit, Quality Assurance unit, Central registry (Sample Receipt subunit, Retention subunit, Specification and Archiving subunit) and Administration unit

1. Chemistry laboratory – This laboratory carries out physicochemical testing of vaccines and other biologics. These include physical description, extractable volume, pH testing, identity test, VVM integrity test, test for aluminum content, test for thiomersal, uniformity of dosage units, particulate matter, and mechanical tests on medical devices etc.
2. Microbiology laboratory – Carries out growth promotion tests, sterility tests, microbial limit tests of non-sterile health care products, antimicrobial effectiveness test, bio burden test etc.
3. Tissue culture laboratory– Carries out ELISA test, virus titration and potency tests on some vaccines and biologics using cell lines.
4. In-vivo laboratory– Performs safety and potency testing of vaccines and other biologics using laboratory animals such as Windstar rats, Guinea pigs, Rabbits, and mice. Tests like specific toxicity of pertussis, abnormal toxicity test, potency testing of follicle stimulating hormone and luteinizing hormone and some vaccines (e.g., Yellow fever and Tetanus vaccine) is carried out. This lab also carries out bacteria endotoxin test (BET).
5. Medical Devices and Serology Laboratory– Conducts quality tests on rapid diagnostic test kits used for the rapid detection of antigens and antibodies in blood samples. It also carries out analysis on other point-of-care devices like glucometer for efficiency and accuracy.
6. Animal facility– Laboratory animal care and management for laboratory testing. Provides the animals with the necessary conditions for animal experiments.
7. Quality Assurance unit- Quality assurance (QA) is a systematic process of determining whether a product or service meets specified requirements. Ensures that testing and related activities are carries out according to ISO 9001 and ISO 17025 standard.
8. Central Registry Unit– This unit consists of;
   1. Sample Receipt subunit – receives of all samples submitted to VBM-LSD and also keeps records of the samples received.
   2. Specification and Archiving subunit – Receives and reviews documents, maintain monographs and issues test to carry out from monographs to testing units.
   3. Retained Sample subunit: Handles all retained sample in the unit.

9. Administration Unit: Dispatches lab results to other directorates, receive documents for official use and carry out other administrative functions.
10. Instrument Maintenance Unit: Management of all laboratory equipment.

OFFICIAL REFERENCE INTERNATIONAL STANDARDS/MONOGRAPHS

Official Reference International standards/Monographs used in VBM-LSD includes; British pharmacopeia, United States pharmacopeia, World Health Organization manual, European Pharmacopoeia and also Validated Manufacturers methods.

FUNCTIONS OF VBM-LSD

• 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 e.g. IPV 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.
• The laboratory ensures maintenance of the Cold Chain, which is monitored via the Vaccine Vial Monitor (VVM) placed on the product. Also, the lab equally carries out some test methodologies to determine the stability of vaccines in the temperatures outside the ones recommended by the manufacturer. In line with the afore mentioned, thermos-stability testing and VVM authenticity test are carried out by the laboratory.
• Lot release of vaccines and other biologics (which includes sampling of vaccines and biologics in conjunction with PID and DER as the need arises);Lot release is key to the control of vaccines and other similar biologics which are inherently variable due to the biological nature of raw material and production process. Therefore, post licensing monitoring for vaccines and other biologics by lot release is considered unique. Lot release is a post-licensure activity conducted by the agency on batches (lots) of vaccines and biologics before they are authorized for sale or use. While lot release has traditionally been an essential regulatory function for vaccines, independent lot release involves the confirmation that each lot meets the specifications in the approved marketing authorization for the product which includes, as a minimum a review of Summary Lot Protocols of the manufacturer, sampling, and laboratory testing.
• Capacity building of Corpers, interns and industrial Trainee Students.
• Breeding and management of laboratory animals in the Animal Facility
• The Laboratory also serves as the Secretariat for the National Advisory Committee on Vaccines and Biologicals.

DOCUMENTATION HIERARCHY IN VBM-LSD