ISO 20404:2023

Indisponible en français

Publiée (Edition 1, 2023)

ISO 20404:2023

CHF 129

Convertir les francs suisses (CHF) dans une autre devise

Résumé

This document specifies general requirements and considerations for the design of packaging used to contain cells for therapeutic use.

This document is applicable to packaging intended to contain the final products of cells for therapeutic use, as well as their starting and intermediate materials.

This document does not apply to:

a) receptacles used for processing cells in manufacturing processes, e.g. cell culture flask or bag;

b) shipping containers containing packages for transportation;

c) services that utilize packages, e.g. storage services.

NOTE 1 Examples of packaging, packages and shipping containers are illustrated in Annex A.

NOTE 2 The design of packaging includes processes to ensure that the designed packaging is manufactured to a required specification through trial manufacturing, testing and implementation of quality management.

NOTE 3 International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Informations générales

État actuel
: Publiée

Date de publication
: 2023-04

Stade
: Norme internationale publiée [60.60]
Edition
: 1
Comité technique :
ISO/TC 276

ICS :
07.080
RSS mises à jour