Aktivní norma | Vydána: 26.01.2023

ISO 23416:2023

General specifications and testing methods for temperature-sensitive medicinal packages in good distribution practice principles
(Spécifications générales et méthodes d´essais relatives aux emballages de médicaments thermosensibles selon les principes de bonnes pratiques de distribution)

Dostupné jazyky: Anglicky

Dostupné provedení: Elektronické PDF, Tištěné

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Podrobné informace

Označení: ISO 23416:2023

Datum vydání: 26.01.2023

Stran: 16

Země: Mezinárodní technická norma

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Anotace

Description / 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.

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