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BS EN ISO 15378:2015

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by

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

Available format(s)

Hardcopy , PDF

Withdrawn date

06-03-2023

Language(s)

English

Published date

30-11-2015

Committee
CH/212
DocumentType
Standard
Pages
78
PublisherName
British Standards Institution
Status
Withdrawn
SupersededBy
Supersedes

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. ISO9001:2008, Quality management systems— Requirements 1.1General 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. NOTE1In 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. NOTE2Statutory 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. ISO9001:2008, Quality management systems— Requirements 1.2Application 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 Clause7, and such exclusions do not affect the organization\'s ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.

Standards Relationship
ISO 15378:2015 Identical
EN ISO 15378:2015 Identical

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