NF EN ISO 15378
NF EN ISO 15378

NF EN ISO 15378

January 2018
Standard Current

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)

Le présent document spécifie les exigences relatives au système de management de la qualité lorsqu''un organisme doit démontrer son aptitude à fournir des articles de conditionnement primaire pour médicaments satisfaisant en permanence aux exigences des clients, y compris les exigences réglementaires et les Normes internationales applicables aux articles de conditionnement primaire.

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Main informations

Collections

National standards and national normative documents

Thematics

Management et performance

Publication date

January 2018

Number of pages

103 p.

Reference

NF EN ISO 15378

ICS Codes

03.120.10   Quality management and quality assurance
11.040.01   Medical equipment in general
55.040   Packaging materials and accessories

Print number

1

International kinship

ISO 15378:2017

European kinship

EN ISO 15378:2017
Sumary
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)

Le présent document spécifie les exigences relatives au système de management de la qualité lorsqu''un organisme doit démontrer son aptitude à fournir des articles de conditionnement primaire pour médicaments satisfaisant en permanence aux exigences des clients, y compris les exigences réglementaires et les Normes internationales applicables aux articles de conditionnement primaire.
Replaced standards (1)
NF EN ISO 15378
NF EN ISO 15378
December 2015
Standard Cancelled
Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)

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