Reference number
ISO 15378:2017
© ISO 2024
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)
Edition 4
2017-09
Read sample
Published (Edition 4, 2017)
This publication was last reviewed and confirmed in 2023. Therefore this version remains current.
This standard has 1 amendment.

ISO 15378:2017

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Format
CHF 194
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Abstract

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.

General information

  • Status
     : Published
    Publication date
     : 2017-09
    Stage
    : International Standard confirmed [90.93]
  • Edition
     : 4
    Number of pages
     : 79
  • Technical Committee :
    ISO/TC 76
  • RSS updates

 Amendments

Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.

Amendment 1

Climate action changes

Edition 2024

Language
Format
CHF 0
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Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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