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Standard Svensk standard · SS-EN ISO 15378:2015

Primärförpackningsmaterial för läkemedel - Särskilda krav för tillämpning av ISO 9001:2008 med hänvisning till "Good Manufacturing Practice" (GMP) (ISO 15378:2015)

Status: Upphävd · Ersätts av: SS-EN ISO 15378:2017

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Omfattning
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.

Ämnesområden

Ledningssystem Medicinsk utrustning allmänt


Produktinformation

Språk: Engelska

Framtagen av: Förbrukningsmaterial inom sjukvården, SIS/TK 330

Internationell titel: 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)

Artikelnummer: STD-8017189

Utgåva: 3

Fastställd: 2015-11-09

Antal sidor: 84

Ersätter: SS-EN ISO 15378:2011

Ersätts av: SS-EN ISO 15378:2017