NF EN ISO 15378

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.

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Main informations

Collections

National standards and national normative documents

Thematics

Management et performance

Publication date

January 2008

Number of pages

75 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 - 28/12/2007

International kinship

ISO 15378:2006

European kinship

EN ISO 15378:2007
Sumary
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
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.

Table of contents
  • Avant-propos
    v
  • 0 Introduction
    vi
  • 0.1 Généralités
    vi
  • 0.2 Approche processus
    vii
  • 0.3 Relation avec l'ISO 9004
    viii
  • 0.4 Compatibilité avec d'autres systèmes de management
    ix
  • 1 Domaine d'application
    1
  • 1.1 Généralités
    1
  • 1.2 Périmètre d'application
    1
  • 2 Références normatives
    2
  • 3 Termes et définitions
    2
  • 4 Système de management de la qualité
    12
  • 4.1 Exigences générales
    12
  • 4.2 Exigences relatives à la documentation
    13
  • 5 Responsabilité de la direction
    15
  • 5.1 Engagement de la direction
    15
  • 5.2 Écoute client
    16
  • 5.3 Politique qualité
    16
  • 5.4 Planification
    16
  • 5.5 Responsabilité, autorité et communication
    17
  • 5.6 Revue de direction
    18
  • 6 Management des ressources
    19
  • 6.1 Mise à disposition des ressources
    19
  • 6.2 Ressources humaines
    19
  • 6.3 Infrastructures
    20
  • 6.4 Environnement de travail
    20
  • 6.5 Activités de maintenance
    22
  • 7 Réalisation du produit
    22
  • 7.1 Planification de la réalisation du produit
    22
  • 7.2 Processus relatifs aux clients
    23
  • 7.3 Conception et développement
    24
  • 7.4 Achats
    27
  • 7.5 Production et préparation du service
    29
  • 7.6 Maîtrise des dispositifs de surveillance et de mesure
    33
  • 8 Mesures, analyse et amélioration
    34
  • 8.1 Généralités
    34
  • 8.2 Surveillance et mesures
    34
  • 8.3 Maîtrise du produit non conforme
    36
  • 8.4 Analyse des données
    37
  • 8.5 Amélioration
    38
  • Annexe A (normative) Exigences des BPF applicables aux articles d'emballage primaire
    40
  • Annexe B (informative) Directives relatives aux exigences de vérification et de validation des articles d'emballage primaire
    44
  • Annexe C (informative) Directives relatives au management du risque pour les articles d'emballage primaire
    53
  • Bibliographie
    60
  • Index
    62
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