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  • BSI
    BS EN ISO 15378:2015 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
    Edition: 2015
    $582.11
    / user per year

Description of BS EN ISO 15378:2015 2015

1.1 General

This International Standard 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.

In this International Standard, 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 9001:2008, Quality management systems — Requirements

1.1   General

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

a)   needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and

b)   aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

NOTE 1   In this International Standard, the term “product” only applies to

a)   product intended for, or required by, a customer,

b)   any intended output resulting from the product realization processes.

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

1.2 Application

This International Standard is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.

ISO 9001:2008, Quality management systems — Requirements

1.2   Application

All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.


Standard NumberBS EN ISO 15378:2015
TitlePrimary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
StatusWithdrawn
Publication Date2015-11-30
Withdrawn Date2023-03-06
ReplacesBS EN ISO 15378:2011
Identical National Standard OfEN ISO 15378:2015, ISO 15378:2015
DescriptorsPackaging materials, Pharmaceutical technology, Consumer-supplier relations, Packages, Quality assurance, Sterilization (hygiene), Packaging, Quality management, Medical equipment, Quality, Drugs
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 83779 1
PublisherBSI
Pages78



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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