60.60 Standard published Jan 26, 2023
ISO
ISO/TC 122 Packaging
International Standard
55.020 Packaging and distribution of goods in general | 11.120.99 Other standards related to pharmaceutics
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.
PUBLISHED
ISO 23416:2023
60.60
Standard published
Jan 26, 2023