WHO global benchmarking tool plus rev. VI+ ver. 1 - NRA Lot Release (LR)

Overview

National Regulatory Authority (NRA) lot release (also called official authority batch release) is a non‐common regulatory function that does not apply to all medical products. Lot release is a system specifically established for the regulatory release of specified biological products. The goal of the regulatory function is to ensure the quality, safety and efficacy of biological products through a regulatory release system. Lot release is done on a lot‐by‐lot basis and takes into account the nature and inherent variability of these products.