ISO22716标准(中英文对照)

1INTERNATIONASTANDARDL国际标准ISO22716Firstedition2007-11-15第一版本发行于2007年11月15日Cosmetics—GoodManufacturingPractices(GMP)—GuidelinesonGoodManufacturingPractices化妆品—良好生产规范（GMP）准则ISO22716:2007(E)标准号ISO22716:2007(E)2ContentsPageIntroduction............................................................................................................................11Scope..................................................................................................................................12Termsanddefinitions...........................................................................................................13Personnel............................................................................................................................44Premises..............................................................................................................................65Equipment............................................................................................................................86Rawmaterialsandpackagingmaterials.........................................................................107Production.........................................................................................................................118Finishedproducts..............................................................................................................149Qualitycontrollaboratory.................................................................................................1510Treatmentofproductthatisoutofspecification..........................................................1711Wastes..............................................................................................................................1712Subcontracting.................................................................................................................1813Deviations.........................................................................................................................1914Complaintsandrecalls...............................................................................................1915Changecontrol................................................................................................................1916Internalaudit...................................................................................................................2017Documentation................................................................................................................203目录介绍.......................................................................11范围.....................................................................12术语和定义.................................................................13员工......................................................................44厂房......................................................................65设备......................................................................86原料和包材................................................................107生产.......................................................................118成品.......................................................................149实验室质量控制制..........................................................1510不合格品的处理...........................................................1711废弃物...................................................................1712外包.....................................................................1813偏差.....................................................................1914投诉和召回...............................................................1915变更控制.................................................................1916内审....................................................................2017文档.....................................................................204IntroductionTheseguidelinesareintendedtoprovideguidanceregardingGoodManufacturingPracticesforcosmeticproducts.Theseguidelineshavebeenpreparedforconsiderationbythecosmeticindustryandtakeintoaccountthespecificneedsofthissector.Theseguidelinesofferorganizationalandpracticaladviceonthemanagementofthehuman,technicalandadministrativefactorsaffectingproductquality.Theseguidelineshavebeenwrittentoallowthemtobeusedfollowingtheflowofproductsfromreceipttoshipment.Additionally,inordertoclarifythewaythisdocumentreachesitsobjectives,a‘principle’isaddedtoeachmajorsection.GoodManufacturingPracticesconstitutethepracticaldevelopmentofthequalityassuranceconceptthroughthedescriptionoftheplantactivitiesthatarebasedonsoundscientificjudgementandriskassessments.TheobjectiveoftheseGMPguidelinesistodefinetheactivitiesthatenableyoutoobtainaproductthatmeetsdefinedcharacteristics.DocumentationisanintegralpartofGoodManufacturingPractices.介绍这份准则为化妆品良好生产规范做出指导，是适合化妆品行业并考虑了行业的具体要求，在人员，技术和影响产品质量的综合因素方面提供了系统性的和实际性的建议。这个指导是为了让员工遵守产品接收到装运的流程下如何去利用资源。为了达到此目的，在每一个章节里都添加了“原则”这一栏。良好生产规范中的质量保证发展观念是通过描述建立在科学有效的判定和风险评估上的工厂活动来完成的，这份准则的目的是为了界定能让你获得达标产品的活动。文件是GMP不可