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)

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.

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Main informations

Collections

National standards and national normative documents

Thematics

Management et performance

Publication date

December 2015

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

International kinship

ISO 15378:2015

European kinship

EN ISO 15378:2015
Sumary
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)

ISO 15378:2015 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.

Replaced standards (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)

<p>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.</p> <p>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.</p>

Standard replaced by (1)
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)

<p>ISO 15378:2017 specifies requirements for a quality management system when an organization:</p> <p>a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and</p> <p>b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.</p> <p>All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.</p> <p>NOTE 1 In this International Standard, the terms "product" or "service" only apply to products and services intended for, or required by, a customer.</p> <p>NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.</p> <p>In addition to ISO 9001, this document specifies Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials 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.</p> <p>In ISO 15378:2017 the term "if appropriate" is used several times. When a requirement is qualified by this phrase, it is deemed to be "appropriate" unless the organization can document a justification otherwise.</p> <p>ISO 15378:2017 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products.</p>

Table of contents
View the extract
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Système de management de la qualité
  • 5 Responsabilité de la direction
  • 6 Management des ressources
  • 7 Réalisation du produit
  • 8 Mesurage, analyse et amélioration
  • Annexe A(normative) Exigences des BPF applicables aux articles d'emballage primaire imprimés
  • Annexe B(informative) Préconisations concernant les exigences de vérification, de qualification et de validation des articles d'emballage primaire
  • Annexe C(informative) Relation entre les articles de la présente Norme internationale et la structure de niveau supérieur
  • Bibliographie
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