ISO 15378-2017 Primary packaging materials for medicinal products - Particular

《ISO 15378-2017 Primary packaging materials for medicinal products - Particular》由会员上传分享，免费在线阅读，更多相关内容在行业资料-天天文库。

1、INTERNATIONALISOSTANDARD15378Fourthedition2017-09Primarypackagingmaterialsformedicinalproducts—ParticularrequirementsfortheapplicationofISO9001:2015,withreferencetogoodmanufacturingpractice(GMP)Articlesd'emballageprimairepourmédicaments—Exigencesparticulièrespourl'applicationdel'ISO9001:2015prenant

2、enconsidérationlesbonnespratiquesdeafbrication(BPF)ReferencenumberISO15378:2017(E)©ISO2017ISO15378:2017(E)COPYRIGHTPROTECTEDDOCUMENT©ISO2017,PublishedinSwitzerlandAllrightsreserved.Unlessotherwisespecified,nopartofthispublicationmaybereproducedorutilizedotherwiseinanyformorbyanymeans,electronicorme

3、chanical,includingphotocopying,orpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbeloworISO’smemberbodyinthecountryoftherequester.ISOcopyrightofficeCh.deBlandonnet8•CP401CH-1214Vernier,Geneva,SwitzerlandTel.+41227490111Fax+41227490947c

4、opyright@iso.orgwww.iso.orgi©ISO2017–AllrightsreservedISO15378:2017(E)ContentsPageForeword.....vIntroduction.....vi1Scope.....12Normativereferences....13Termsanddefinitions....23.1Termsrelatedtoorganization...23.2Termsrelatedtoactivity....33.3Termsrelatedtosystem....43.4Termsrelatedtorequirement...

5、53.5Termsrelatedtoprocess....63.6Termsrelatedtoresults....73.7Termsrelatedtodata,informationanddocument..83.8Termsrelatedtoaction....93.9Termsrelatedtocharacteristic...103.10Termsrelatedtodetermination...103.11Termsrelatingtoriskmanagement...114Contextoftheorganization....124.1Understandingtheorgan

6、izationanditscontext..124.2Understandingtheneedsandexpectationsofinterestedparties..124.3Determiningthescopeofthequalitymanagementsystem..134.4Qualitymanagementsystemanditsprocesses...135Leadership.....145.1Leadershipandcommitment...145.1.1General....145.1.2Customerfocus....155.1.3Customeraudits...

7、.155.2Policy.....155.3Organizationalroles,responsibilitiesandauthorities..166Planning.....176.1Actionstoaddressrisksandopportunities...176.2Qualityobjectivesandplanningtoachievethem...186.3Planningofchanges