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  • BSI
    BS EN 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: 2017
    $569.57
    / user per year

Description of BS EN ISO 15378:2017 2017

ISO 9001:2015, Quality management systems — Requirements

1 Scope

This International Standard specifies requirements for a quality management system when an organization:

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

  2. 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 this document 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.

This document is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products.



Standard NumberBS EN ISO 15378:2017
TitlePrimary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
StatusWithdrawn
Publication Date2017-11-15
Withdrawn Date2024-09-18
ReplacesBS EN ISO 15378:2015
Identical National Standard OfEN ISO 15378:2017, ISO 15378:2017
DescriptorsConsumer-supplier relations, Sterilization (hygiene), Packages, Drugs, Packaging, Packaging materials, Medical equipment, Quality assurance, Quality management, Pharmaceutical technology, Quality
ICS03.100.70 Management systems, 11.040.01 Medical equipment in general, 03.120.10 Quality management and quality assurance
CommitteeCH/212
ISBN978 0 580 95555 6
PublisherBSI
Pages94

The following editions for this book are also available...

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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