BS EN ISO 15378:2007 - Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)

BS EN ISO 15378:2007

Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)

Status : Revised, Withdrawn   Published : June 2006 Replaced By : BS EN ISO 15378:2011

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Standard NumberBS EN ISO 15378:2007
TitlePrimary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)
StatusRevised, Withdrawn
Publication Date30 June 2006
Withdrawn Date30 November 2011
Normative References(Required to achieve compliance to this standard)ISO 9001:2000, ISO 9000:2000, ISO 14644-1:1999, ISO 14644-2:2000, ISO 14644-3, ISO 14644-4:2001, ISO 14644-5
Informative References(Provided for Information)ISO 9004:2000, ISO 10012:2003, ISO 11135, ISO 11137-1, ISO 11137-2, ISO 13485:2003, ISO 14001:2004, ISO 14644-7:2004, ISO 14644-8, ISO 14698-1:2003, ISO 14698-2:2003, ISO 14937:2000, ISO 14971:2000, ISO 19011:2002, ISO/IEC 90003:2004, ISO/IEC Guide 2:1996, VIM:1993, IEC 60601-1-4:2000, IEC 60812:1985, IEC 61025:1990, IEC 61882:2001, ISO/IEC Guide 51:1999, ISO 14971:2001
Replaced ByBS EN ISO 15378:2011
International RelationshipsEN ISO 15378:2007,ISO 15378:2006
Amended ByAMD 17315, August 2007.
Draft Superseded By07/30160645 DC
DescriptorsPackaging materials, Drugs, Pharmaceutical technology, Packaging, Packages, Quality management, Quality assurance, Quality, Consumer-supplier relations, Medical equipment, Sterilization (hygiene)
ICS03.120.10
11.040.01
Title in FrenchMateriaux d'emballage primaire pour medicaments. Exigences particulieres pour l'application de l'ISO 9001:2000 prenant en consideration les bonnes pratiques de fabrication (BPF)
Title in GermanPrimaerverpackungen fuer Arzneimittel. Besondere Anforderungen fuer die Anwendung von ISO 9001:2000 entsprechend der Guten Herstellungspraxis (GMP)
CommitteeCH/212
ISBN978 0 580 59781 7
PublisherBSI
FormatA4
DeliveryNo
Pages72
File Size2.975 MB
Price£274.00


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