Standard

ISO 23416:2023

Jan 2023 Current

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Language English

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Abstract

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.

Products specifications

Standard from ISO
Published: January 26 2023
Edition: 1
Document type: IS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.120.99
ICS: 55.020
International TC: ISO/TC 122

Extended editions Extended editions (0)

Version history Related Corrigenda and Amendments (0)

Abstract

Products specifications