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DIN EN ISO 15378:2018-04
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP).
Translate name
STANDARD published on 1.4.2018
The information about the standard:
Designation standards: DIN EN ISO 15378:2018-04
Publication date standards: 1.4.2018
SKU: NS-808257
The number of pages: 105
Approximate weight : 346 g (0.76 lbs)
Country: German technical standard
Category: Technical standards DIN
The category - similar standards:
Quality management and quality assuranceMedical equipment in generalMedicamentsPackaging materials and accessories
Annotation of standard text DIN EN ISO 15378:2018-04 :
Primärpackmittel für Arzneimittel - Besondere Anforderungen für die Anwendung von ISO 9001:2015 entsprechend der Guten Herstellungspraxis (GMP).
These changes apply to this standard:
DIN EN ISO 15378/A1:2024-11
Change
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Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) - Amendment 1: Climate action changes.
(Primärpackmittel für Arzneimittel - Besondere Anforderungen für die Anwendung von ISO 9001:2015 entsprechend der Guten Herstellungspraxis (GMP) - Änderung 1: Ergänzung zu klimabezogenen Maßnahmen.)
Change published on 1.11.2024
Selected format:Show all technical information.
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