BS EN ISO 15378:2017 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)

BS EN ISO 15378:2017

Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)

Status : Current   Published : November 2017

Format
PDF

Format
HARDCOPY



BS EN ISO 15378:2017 - Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015

This document identifies Good Manufacturing Practice (GMP) principles and specifies requirements for a quality management system applicable to primary packaging materials for medicinal products.




Standard NumberBS EN ISO 15378:2017
TitlePrimary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
StatusCurrent
Publication Date15 November 2017
Normative References(Required to achieve compliance to this standard)ISO 14698-2:2003, ISO 9000:2015, ISO 14698-1:2003
Informative References(Provided for Information)ISO 10014:2006, ISO 14937:2009, ISO 14644-5:2004, IEC 61025:2006, ISO 14644-7:2004, ISO 11135:2014, ISO 10012:2003, ISO 14971:2007, ISO 19011:2018, IEC 61882:2016, IEC 60300-1:2014, ISO/IEC 90003:2014, ISO 10003:2007, ISO 9001:2015, ISO/TS 11139:2006, ISO 14644-2:2000, ISO 10018:2012, ISO/TR 10017:2003, ISO/IEC Guide 99:2007, ISO 10019:2005, ICH Q10, ISO 9001:2008, ISO 31010:2009, ISO/IEC Guide 2, ISO/IEC Guide 73, ISO 14644-1, ICH Q9, ISO 10007:2017, ISO 14644-4:2001, BS EN ISO 19011:2018, ISO 11137-1:2006, IEC 61160:2005, ISO 14644-8:2013, ISO 9004:2009, ISO 13485:2016, ISO/TR 10013:2001, ISO 31000:2009, ISO 10015:1999, ISO 10006:2017, ISO 10002:2004, IEC 60601-1:2005, IEC 60812:2006, ISO 10004:2012, ISO 10001:2007, ISO 14001:2015, ISO 14644-3:2005, ISO 37500:2014, ISO 11137-2:2012, ISO 10008:2013, ISO 10005:1995
ReplacesBS EN ISO 15378:2015
International RelationshipsEN ISO 15378:2017,ISO 15378:2017
Draft Superseded By16/30347647 DC
DescriptorsQuality assurance, Medical equipment, Packaging materials, Packaging, Drugs, Packages, Sterilization (hygiene), Consumer-supplier relations, Quality management, Pharmaceutical technology, Quality
ICS03.100.70
03.120.10
11.040.01
Title in FrenchArticles d'emballage primaire pour médicaments. Exigences particulières pour l'application de l'ISO 9001:2015 prenant en considération les Bonnes Pratiques de Fabrication (BPF)
CommitteeCH/212
ISBN978 0 580 95555 6
PublisherBSI
FormatA4
DeliveryYes
Pages94
File Size2.438 MB
Price£280.00


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