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Status : Revised, Superseded, Withdrawn   Published : November 2011 Replaced By : BS EN ISO 15378:2015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StatusRevised, Superseded, Withdrawn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Withdrawn Date30 November 2015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)ISO 14644-3, 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 RelationshipsEN ISO 15378 (ISO 15378:2011),ISO 15378:2011
DescriptorsConsumer-supplier relations, Packaging materials, Pharmaceutical technology, Packages, Drugs, Quality assurance, Quality management, Packaging, Medical equipment, Quality, Sterilization (hygiene)
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 Size1.129 MB
Price£274.00


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