The NAFDAC Guidance Document and Guideline for Lot Release of Human Vaccines and Other Biologicals(VBMLS-GDL-001-01) provides guide for the lot release of human vaccines and other Biologicals. Document is in compliance with the WHO Guidelines for independent lot release of vaccines by regulatory authorities. The lot release of vaccines and other Biologicals by regulatory authorities is part of the regulation of vaccines and other Biologicals and involves the independent assessment of each lot of a licensed vaccine and other Biologicals before it is released into the market. This assessment is based, as a minimum, on the review of manufacturers’ summary protocols. It may be supplemented by other documents such as the release certificate from the responsible national regulatory authority (NRA) or national control laboratory (NCL) and, in some circumstances, by testing.
A lot is the defined quantity of starting material, packaging material, or product processed in a single/ series of processes so that it is expected to be homogeneous. It may sometimes be necessary to divide a lot into several sub-lots, which are later accumulated to form a final homogeneous lot. In continuous manufacture, the lot should correspond to a defined fraction of the production, characterized by its intended homogeneity. The lot size can be defined either as a fixed quantity or as the amount produced in a fixed time interval. Read more
