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

BS EN ISO 15378:2015

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

Status : Current, Superseded, Work in hand   Published : November 2015 Replaced By : BS EN ISO 15378:2017

Format
PDF

Format
HARDCOPY






Standard NumberBS EN ISO 15378:2015
TitlePrimary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
StatusCurrent, Superseded, Work in hand
Publication Date30 November 2015
Normative References(Required to achieve compliance to this standard)ISO 14698-1, ISO 14698-2, ISO 9000:2005, ISO 9001:2008
Informative References(Provided for Information)ICH Q9, ISO 11135, ISO 14971, ISO Guide 73, ICH Q10, ISO 14644-7, ISO 9004, IEC 61025, ISO 14644-8, ISO 14937:2009, ISO 14644-5, ISO/IEC 90003, ISO 14644-2, ISO/IEC Guide 2, IEC 61882, IEC 60601-1, ISO 14644-1, ISO 14644-4, ISO 13485, ASTM E 2500, ISO 14001:2004, ISO 9001, ISO 11137-1, ISO/TS 11139, ISO 11137-2, ISO 10012, ISO 31000:2018, ISO 19011, IEC 60812, ISO/IEC Guide 99:2007, IEC 31010, ISO 10007:2017, ISO 14644-3
Replaced ByBS EN ISO 15378:2017
ReplacesBS EN ISO 15378:2011
International RelationshipsEN ISO 15378:2015,ISO 15378:2015
Draft Superseded By14/30287226 DC
DescriptorsPackaging, Sterilization (hygiene), Quality assurance, Packages, Consumer-supplier relations, Pharmaceutical technology, Packaging materials, Quality management, Medical equipment, Quality, Drugs
ICS03.100.70
03.120.10
11.040.01
Title in FrenchArticles de conditionnement primaire pour médicaments. Exigences particulières pour l'application de l'ISO 9001:2008 prenant en considération les Bonnes Pratiques de Fabrication (BPF)
Title in GermanPrimärpackmittel für Arzneimittel. Besondere Anforderungen für die Anwendung von ISO 9001:2008 entsprechend der Guten Herstellungspraxis (GMP)
CommitteeCH/212
ISBN978 0 580 83779 1
PublisherBSI
FormatA4
DeliveryYes
Pages78
File Size1.161 MB
Price£274.00


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