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.