NF EN ISO 15378

NF EN ISO 15378

January 2012
Standard Cancelled

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)

ISO 15378:2011 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.ISO 15378:2011 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.

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Main informations

Collections

National standards and national normative documents

Thematics

Management et performance

Publication date

January 2012

Number of pages

82 p.

Reference

NF EN ISO 15378

ICS Codes

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

Classification index

S93-200

Print number

1 - 20/12/2011

International kinship

ISO 15378:2011

European kinship

EN ISO 15378:2011
Sumary
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)

ISO 15378:2011 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.

ISO 15378:2011 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.

Replaced standards (1)
NF EN ISO 15378
January 2008
Standard Cancelled
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)

ISO 15378:2006 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials. ISO 15378:2006 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.

Standard replaced by (1)
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)

ISO 15378:2015 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.

Table of contents
  • Avant-propos
    v
  • 0 Introduction
    vi
  • 0.1 Généralités
    vi
  • 0.2 Approche processus
    viii
  • 0.3 Relations avec l'ISO 9004
    x
  • 0.4 Compatibilité avec d'autres systèmes de management
    x
  • 1 Domaine d'application
    1
  • 1.1 Généralités
    1
  • 1.2 Périmètre d'application
    1
  • 2 Références normatives
    2
  • 3 Termes et définitions
    3
  • 4 Système de management de la qualité
    12
  • 4.1 Exigences générales
    12
  • 4.2 Exigences relatives à la documentation
    14
  • 5 Responsabilité de la direction
    17
  • 5.1 Engagement de la direction
    17
  • 5.2 Écoute client
    17
  • 5.3 Politique qualité
    18
  • 5.4 Planification
    18
  • 5.5 Responsabilité, autorité et communication
    19
  • 5.6 Revue de direction
    20
  • 6 Management des ressources
    21
  • 6.1 Mise à disposition des ressources
    21
  • 6.2 Ressources humaines
    21
  • 6.3 Infrastructures
    23
  • 6.4 Environnement de travail
    23
  • 6.5 Activités de maintenance
    24
  • 7 Réalisation du produit
    25
  • 7.1 Planification de la réalisation du produit
    25
  • 7.2 Processus relatifs aux clients
    26
  • 7.3 Conception et développement
    28
  • 7.4 Achats
    31
  • 7.5 Production et préparation du service
    33
  • 7.6 Maîtrise des équipements de surveillance et de mesure
    39
  • 8 Mesures, analyse et amélioration
    40
  • 8.1 Généralités
    40
  • 8.2 Surveillance et mesurage
    40
  • 8.3 Maîtrise du produit non conforme
    43
  • 8.4 Analyse des données
    44
  • 8.5 Amélioration
    44
  • Annexe A (normative) Exigences des BPF applicables aux articles de conditionnement primaire imprimés
    46
  • Annexe B (informative) Directives relatives aux exigences de vérification et de validation des articles de conditionnement primaire
    50
  • Annexe C (informative) Directives relatives au management du risque pour les articles de conditionnement primaire
    59
  • Bibliographie
    66
  • Index
    68
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