16/30347647 DC - BS EN ISO 15378. Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)

16/30347647 DC

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

Status : Draft for public comment, Withdrawn   Published : October 2016

Format
PDF

Format
HARDCOPY






Standard Number16/30347647 DC
TitleBS EN ISO 15378. Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
StatusDraft for public comment, Withdrawn
Publication Date05 October 2016
Withdrawn Date15 November 2017
Normative References(Required to achieve compliance to this standard)ISO 9000:2015, ISO 14698-2, ISO 14698-1
Informative References(Provided for Information)ISO 10012, ISO 14937:2009, IEC 61160, ISO 10014, ISO 9004, ISO 14971:2007, ISO 10004, ISO 10001, ISO 37500, ISO 13485, ISO 14644-2, ISO 14644-8, ISO 14644-7, ISO 10003, ISO 10005, IEC 61025, ISO 10019, ISO/TR 10013, ISO 9001, ISO/TR 10017, ISO/TS 11139, ISO 14644-4, ISO 11137-1, ISO 14644-5, ISO/IEC Guide 2, ISO 14644-1, ISO 14001, ISO 31000:2018, IEC 60812, ISO 10018, ISO 10007:2017, ISO 19011, ISO 14644-3, ISO 9001:2015, ISO/IEC Guide 99:2007, ISO/IEC 31010:2009, ISO 10015, IEC 60300-1, ISO 10002, ISO 11137-2, IEC 61882, ISO 10008, ISO 11135, IEC 60601-1, ISO 10006, ISO/IEC 90003, ISO/IEC Guide 73, ASTM E 2500
International RelationshipsISO/DIS 15378
Draft Expiry Date26 November 2016
DescriptorsQuality, Packaging materials, Quality management, Pharmaceutical technology, Quality assurance, Sterilization (hygiene), Packaging, Packages, Medical equipment, Drugs, Consumer-supplier relations
ICS03.100.70
03.120.10
11.040.01
11.120.10
55.040
CommitteeCH/212
PublisherBSI
FormatA4
DeliveryYes
Pages91
File Size2.367 MB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


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