BS EN ISO 15378:2011 - 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 15378:2011

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

Status : Revised, Superseded, Withdrawn   Published : November 2011 Replaced By : BS EN ISO 15378:2015

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Standard NumberBS EN ISO 15378:2011
TitlePrimary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
StatusRevised, Superseded, Withdrawn
Publication Date30 November 2011
Withdrawn Date30 November 2015
Normative References(Required to achieve compliance to this standard)BS EN ISO 14644-3:2019, ISO 14644-3:2019, ISO 14644-2, ISO 9001:2008, ISO 14644-5, ISO 14644-1, ISO 9000:2005
Informative References(Provided for Information)ISO 14644-4, ISO 14698-2, ISO 11137-1, ISO 14698-1, ISO 9001:2008, IEC 61025, ISO 11135, ISO 14644-7, ISO 14644-8, ISO/IEC 90003:2004, ISO 9004, ISO 13485:2003, ISO 11137-2, IEC 60601-1-4, ISO 19011, ISO 14001:2004, ISO 10007, ISO 14937:2009, ISO 10012, ISO/IEC Guide 51:1999, IEC 61882, ISO/IEC Guide 2, VIM:1993, ISO 14971:2007, IEC 60812
Replaced ByBS EN ISO 15378:2015
ReplacesBS EN ISO 15378:2007
International RelationshipsISO 15378:2011,EN ISO 15378:2011
DescriptorsSterilization (hygiene), Quality, Medical equipment, Packaging, Quality management, Quality assurance, Consumer-supplier relations, Drugs, Packages, Pharmaceutical technology, Packaging materials
ICS03.100.70
03.120.10
11.040.01
Title in FrenchArticles de conditionnement primaire pour medicaments. 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 68838 6
PublisherBSI
FormatA4
DeliveryNo
Pages82
File Size1.599 MB
Price£280.00


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