Norm

NEN-ISO 15378:2006 en

Primaire verpakkingsmaterialen voor medicinale producten - Speciale eisen voor de toepassing van de ISO 9001:2000, met referentie tot Produktieleidraad (GMP)

  • Deze norm is ingetrokken sinds 02-08-2007

161,21

Over deze norm

Status Ingetrokken
Aantal pagina's 59
Commissie Transfusie, infusie en injectieapparatuur voor medische toepassingen
Gepubliceerd op 01-03-2006
Taal Engels
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. 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.

Details

ICS-code 03.120.10
11.040.01
Nederlandse titel Primaire verpakkingsmaterialen voor medicinale producten - Speciale eisen voor de toepassing van de ISO 9001:2000, met referentie tot Produktieleidraad (GMP)
Engelse titel Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)
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