Vaccines, Biologicals, & Medical Devices
Vaccines & Biologicals Section
NAFDAC Guideline documents for product registration.
Information about safety of vaccines.
Information on Covid 19 Vaccines authorized in Nigeria
Vaccine publications
Sampling is an operation to select a portion of products for the purpose of testing in the laboratory.
VBM-LSD carries out sampling of vaccines and other biologics with a procedure that is well documented to show batch number, date and place of sampling, sampling method used, description of product sampled, notes on possible abnormalities, other observations, and name and signature of inspectors and consignee.
VBM-LSD carries out sampling of vaccines and other biologicals in collaboration with Ports inspectorate directorate.
A systematic random sampling is adopted on a batch-by-batch basis for the same product and every form of bias is eliminated.
VBM-LSD personnel are adequately trained in the practical aspects of sampling and qualified to perform sampling operation with sufficient knowledge of biological substances making them well equipped to execute the work effectively and safely.
Samples are kept in cold boxes to maintain cold chain of product all through the period of transportation to the laboratory.
Quality documents required from Consignee during sampling include:
Certificate of Analysis (CoA): The CoA lists tests performed on a particular sample with the results obtained and the acceptance criteria applied, followed by an indication of whether or not the sample complies with specification. The compendia method used for the test should also be shown.
Summary lot protocol: This document describes the key steps and critical test results at each step of the production process.
Certificate of Release from the NRA where the product originates from.
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NAFDAC regulation documents for vaccine and biologics regulation.
- Download the NAFDAC Vaccine Mapping processย here
Responses to FAQ.
Lot release is a basic requirement in the control of vaccines. It is to confirm the production of each batch or lot is consistent since every lot is distinct.
Biologicals are inherently variable due to the nature of the starting materials, manufacturing process and test methods. Post licensing monitoring of vaccines and biologics involves lot by lot release. The objective is to verify that a batch is in conformity with the approved specification and that it meets the product license or market authorization. The importance is that it ensures that each batch of the vaccine are safe and potent; in addition to GMP Inspection, Post Market Surveillance, and assurance of proper storage.
The documents required for lot release of a product include.
- Summary Lot Protocol (for protocol review)
- Certificate of Analysis
- Certificate of Release from the NRA where the product originates from.
VBM-LSD issues lot release certificates on imported vaccines after analysis and document review.
Lot Release Certificates Issued
Vaccines & Biologicals Programmes & Initiatives
Resources for
- Consumers
- Food Industry
- Healthcare Professionals
- Additional Food Resources
Vaccine Services
Register a
Product
Analyze Vaccine &
Biological samples
Report Adverse
Drug Reactions/AEFI
Drug Evaluation and Research (DER) Directorate
- NAFDAC Office Complex Plot 1, Isolo Industrial Area Oshodi-Apapa Expressway Isolo, Lagos State.
Drug Registration and Regulatory Affairs (DRR) Directorate
- NAFDAC Office Complex Plot 1, Isolo Industrial Area Oshodi-Apapa Expressway Isolo, Lagos State.
Vaccines Biologicals and Medical Devices Laboratory Services Directorate (VBM-LSD)
- Second Floor, Laboratory Services, 8/10 Merret Road, Medical Compound, Yaba, Lagos State, Nigeria.
