International Standard
ISO 15378:2017
Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
Reference number
ISO 15378:2017
Edición 4
2017-09
© ISO 2024
International Standard
Vista previa
No disponible en español
Publicado (Edición 4, 2017)
Esta norma se revisó y confirmó por última vez en 2023. Por lo tanto, esta versión es la actual.
Esta norma tiene 1 modificaciones.

ISO 15378:2017

Formato
Idioma
CHF 194
Convertir Franco suizo (CHF) a tu moneda

Resumen

ISO 15378:2017 specifies requirements for a quality management system when an organization:

a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and

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.

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.

NOTE 1 In this International Standard, the terms "product" or "service" only apply to products and services intended for, or required by, a customer.

NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.

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.

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.

ISO 15378:2017 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products.

Informaciones generales

  • Estado
     : Publicado
    Fecha de publicación
     : 2017-09
    Etapa
    : Norma Internacional confirmada [90.93]
  • Edición
     : 4
    Número de páginas
     : 79
  • Comité Técnico :
    ISO/TC 76
  • RSS actualizaciones

 Modificaciones

Las enmiendas se emiten cuando se decide que puede ser necesario agregar nuevo material a un documento de normalización existente. También pueden incluir correcciones editoriales o técnicas que deban aplicarse al documento existente.

Amendment 1

Climate action changes

Edición 2024

Formato
Idioma
CHF 0
Gastos de envío no incluidos

Ciclo de vida

Objetivos de Desarrollo Sostenible

Esta norma contribuye al siguiente Objetivo de Desarrollo Sostenible

3
Good Health and Well-being

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

  2. Tienda
  3. Standards catalogue
  4. ICS
  5. 03
  6. 03.100
  7. 03.100.70
  8. ISO 15378:2017