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ISO 23416:2023
General specifications and testing methods for temperature-sensitive medicinal packages in good distribution practice principles
Translate name
STANDARD published on 26.1.2023
The information about the standard:
Designation standards: ISO 23416:2023
Publication date standards: 26.1.2023
SKU: NS-1102432
The number of pages: 16
Approximate weight : 48 g (0.11 lbs)
Country: International technical standard
Category: Technical standards ISO
The category - similar standards:
Packaging and distribution of goods in generalOther standards related to pharmaceutics
Annotation of standard text ISO 23416:2023 :
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.
