Hivatkozási szám

MSZ EN ISO 15378:2016

Dokumentumazonosító

162479

Cím

Gyógyszerek elsődleges csomagolóanyagai. Az ISO 9001:2008 alkalmazásának sajátos követelményei, tekintettel a helyes gyártási gyakorlatra (GMP) (ISO 15378:2015)

Angol cím

Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015)

Alkalmazási terület

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.

ICS

03.100.70 Irányítási rendszerek

11.040.01 Orvostechnikai berendezések általában

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2016-04-01

A visszavonás napja

2018-04-01

Forrás

idt EN ISO 15378:2015; idt ISO 15378:2015

Előd

MSZ EN ISO 15378:2012

Utód

MSZ EN ISO 15378:2018

Módosítás

SZK-közlemények

Kapcsolódó európai jogszabály

A szabvány

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