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1、?ISO2017Primarypackagingmaterialsformedicinalproducts—ParticularrequirementsfortheapplicationofISO9001:2015withreferencetogoodmanufacturingpractice(GMP)Articlesdemballageprimairepourmdicaments—Exigencesparticulirespourla

2、pplicationdelISO9001:2015prenantenconsidrationlesbonnespratiquesdefabrication(BPF)INTERNATIONALSTANDARDISO15378Fourthedition201709ReferencenumberISO15378:2017(E)ISO15378:2017(E)Foreword...................................

3、.......................................................................................................................................................................................................vIntroduction........

4、........................................................................................................................................................................................................................vi1S

5、cope........................................................................................................................................................................................................................

6、.........12Normativereferences......................................................................................................................................................................................13Termsa

7、nddefinitions.....................................................................................................................................................................................23.1Termsrelatedtoorganiza

8、tion....................................................................................................................................................23.2Termsrelatedtoactivity..........................................

9、.......................................................................................................................33.3Termsrelatedtosystem.............................................................................

10、.....................................................................................43.4Termsrelatedtequirement............................................................................................................

11、........................................53.5Termsrelatedtoprocess...........................................................................................................................................................

12、.....63.6Termsrelatedtesults..................................................................................................................................................................73.7Termsrelatedtodatainformat

13、ionanddocument..................................................................................................83.8Termsrelatedtoaction....................................................................................

14、................................................................................93.9Termsrelatedtocharacteristic............................................................................................................

15、..................................103.10Termsrelatedtodetermination............................................................................................................................................103.11Termsre

16、latingtiskmanagement...................................................................................................................................114Contextoftheorganization..........................................

17、..........................................................................................................................124.1Understandingtheorganizationanditscontext....................................................

18、................................................124.2Understandingtheneedsandexpectationsofinterestedparties...........................................................124.3Determiningthescopeofthequalitymanagementsystem.

19、.........................................................................134.4Qualitymanagementsystemanditsprocesses.......................................................................................................1

20、35Leadership...............................................................................................................................................................................................................1

21、45.1Leadershipandcommitment..................................................................................................................................................145.1.1General.................................

22、..................................................................................................................................................145.1.2Customerfocus......................................................

23、.........................................................................................................155.1.3Customeraudits..............................................................................................

24、...............................................................155.2Policy..................................................................................................................................................

25、..........................................................155.3Organizationalrolesresponsibilitiesandauthorities.......................................................................................166Planning..........

26、............................................................................................................................................................................................................176.1Actionstoad

27、dressrisksandopportunities................................................................................................................176.2Qualityobjectivesandplanningtoachievethem....................................

28、...............................................................186.3Planningofchanges.......................................................................................................................................

29、..................................197Support................................................................................................................................................................................

30、........................................197.1Resources......................................................................................................................................................................

31、............................197.1.1General..................................................................................................................................................................................

32、.197.1.2People.....................................................................................................................................................................................197.1.3Infrastructure....

33、..............................................................................................................................................................207.1.4Environmentfortheoperationofprocesses..................

34、......................................................................217.1.5Monitoringandmeasuringresources........................................................................................................237.1.6O

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