1 Scope
This document describes the general specifications of temperature-sensitive medicinal
packaging based on the principles of good distribution practice ( GDP ). It also specifies test methods to validate the package performance for temperature-sensitive medicinal products . This covers the procedures of temperature-recording and testing methods on the performance of insulated containers such as dimensions, weights, storage capacity and robustness in temperature-controlling.
This document does not guarantee the quality and safety of all medicinal products . Under special circumstances where the weight or the characteristics of the products
and environment show specific conditions, agreements are followed. This document does
not cover the active packaging system, but only covers the passive packaging system
able to control the desired temperature without any power sources.
BS ISO 23416:2023 history
2023BS ISO 23416:2023 General specifications and testing methods for temperature-sensitive medicinal packages in good distribution practice principles