EUGMP附录1无菌药品生产201
Aftermanypostponements,thelongawaitedAnnex1draftoftheEUGMPGuidelinehasfinallybeenpublishedon20December,.Whilethechaptersonintegritytestingandvisualinspectionofinjectablesusedtoberathershort,thedraftnowcontainsseveralupdates.Besidesthepassagesoncrimpingandthehandlingofstopperedvialsbeforecrimping,thecurrentlyapplicableAnnex1onlycontainstwosectionsontheimportantissuesofintegritytestingandvisualinspection:paragraphcallsfor%integritytestingforcontainerssealedbyfusion,andparagraphdescribestherequirementsfor%visualcontrolofparenteralsinatotalofsevenlines.
欧盟GMP附录1草案于-12-20发布。旧版指南中关于注射剂密封性测试及外观检查的章节非常短。现如今新指南草案有了一些更新。除了轧盖及轧盖前已压塞瓶子的处理，现行版附录1关于这两个重要事项密封性测试及外观检查有两个段落：第段要求对熔封的包装容器进行%完整性测试，第段只用7行字描述了对注射剂进行%外观检查的要求。
Thenewdocumentspecificallystateswhichcontainersaretobe%testedforintegrity:glassorplasticampoules(thisalsoincludesBFScontainers)aswellasLargeVolumeParenteral(LVP)orSmallVolumeParenteral(SVP)bagsclosedbyfusion.Forothercontainers,astatisticallyvalidsamplingplanshouldbeimplemented.Visualinspectionaloneisexplicitlyruledoutasanacceptableintegritytestingmethod.
而新指南特别指出需要进行%密封性测试的包装容器：玻璃或塑料安瓿（BFS容器指南同样要求）、熔封制备的大输液袋或小容量注射剂。对于其他容器，应执行具备统计学意义的取样计划。单独的目视检查不被认为可接受的完整性测试方法。
Containerssealedundervacuumaretobetestedforthemaintenanceofthevacuumafterapreviouslydefined,appropriateperiodoftimeandduringshelflife.The"and"isunclearinthisinstance.Also,thereisnoindicationastotheextentofthistesting.Thereisalsoanewnoticestatingthattransportationvalidationstudiesaretobeconsideredforthevalidationofcontainerclosuresystems.
指南中有一句话“密封在真空条件下的容器应在既定时间后和货架期内测试其真空度的维持水平。.”这里面“和”的意思不够清晰。此外，也没有指示表明这种测试的程度。还有一个新的提示，说容器密闭系统验证应考虑运输验证。
Thetopicvisualinspectionofparenteralshasbeenexpandedtofourparagraphsinthedraft(8.26-8.29).Therequirementfor%visualinspectionisunchanged(8.26).Thereis,however,referencetotheuseofqualityriskmanagementprinciplesfordeterminingthecriticalityofdefects.
在此新草案中关于注射剂外观检查这一话题已扩充到4段内容8.26~8.29。对于%外观检查的要求没变（8.26），但也提及运用质量风险管理原则来确定缺陷关键级别。
Moreover,therehastobeadefectlibrarycontainingalltypicaldefectsofaprocess.Differentdefecttypesaretobedefinedandthedefectcountintheindividualcategoriesistobemonitoredbytrending.Deviationsfromthetypicallevelofdefectsoughttoinfluencethereleaseprocessforthebatchinvolved.Criticaldefectsshall"notbeidentifiedduringanysubsequentsamplingofacceptablecontainers"after%visualcontrol;thiswouldputthepreviousinspectionprocessindoubt.ThisistheonlyreferencetopossibleAQLtestingaspartofvisualcontrolasisrequiredbytheAmericanPharmacopoeiaUSP(Chapterand1),eventhoughthereisnoexplicitmentioningofAQLtesting.
此外，还需建立包含所有典型缺陷类型的缺陷库。明确定义不同的缺陷类型，对各类缺陷的数量应监测其趋势。缺陷超过日常水平可能影响相关批次产品放行。通过%外观检查后的容器，在随后的抽检中不应再次被发现关键缺陷，否则将会引起对前面%外观检查效果的质疑。
Theparagraphonmanualvisualinspectionfocusesmainlyonthetrainingandqualificationofstaffinvisualinspection.Thequalificationshouldincludeworstcaseconditionslikelinespeed,inspectiontimeorfatigueforexampleattheendofashift.Asforbreaktimes,thedraftonlysays:frequent.
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