** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6
** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6

Vaccines & Biologicals

Vaccines & Biologicals Section

Vaccines & Biologicals Guidelines

NAFDAC Guideline documents for product registration.

Sampling of Vaccines and Biopharmaceuticals

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.

 

 

Vaccines & Biologicals Regulations

NAFDAC regulation documents for vaccine and biologics regulation.

Lot Release

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.

  1. Summary Lot Protocol (for protocol review)
  2. Certificate of Analysis
  3. 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

Resources for

Vaccine Services

Analyze Vaccine &
Biological samples

Drug Evaluation and Research (DER) Directorate

Drug Registration and Regulatory Affairs (DRR) Directorate

National Vaccine and Biologics Laboratory (NVBL) Directorate