自查系统Self Inspection 不合格物料的控制Rejection controls III.职责RESPONSIBILITIES 1.TrackWise系统管理员TrackWise System Administrator 为公司用户提供一线系统支持 Provide first line system support to site-end-users. 2.审计负责人Lead Auditor 2.1审计负责人应该是不受被审计部门约束的,至少其工作职能是独立于被...
用TrackWise作为管理审计报告的系统，并跟踪所有相关行动,确保DXC符合公司总部的指示和政策、cGMP和产品分布地的政府法律机构所建立的要求。Assure DXC is operating in compliance with corporate guidelines and policies, current GMP’s and any other requirements established by the Regulatory Agencies where the produ...
excerptedfromFDA'sInspectionOperationsManual,mayserveasguidelinesforeffectiveself-inspection.Agoodinspectionscoremeansthatanestablishmentfollowsgoodmanufacturingpractice. Guidelines BuildingandFacilities.Checkwhether Buildingsusedinthemanufactureorstorageofcosmeticsareofsuitablesize,designandconstructiontopermitunobstructed...
10、ersonnel 第三章第三章 厂房与设备 Premises and Equipment 第八章第八章 投诉和药品召回Complaints and Product Recall 第九章第九章 自检Self Inspection 基本要求1 质量管理 共同承担义务共同承担义务质量保证系统质量保证系统足够配备资源足够配备资源 达到这一质量目标是高级达到这一质量目标是高级 管理层的责任...
Chapter1GeneralProvisionChapter2QualityManagementChapter3OrganizationandPersonnelChapter4PremisesandFacilitiesChapter5EquipmentChapter6MaterialsandProductsChapter7QualificationandValidationChapter8DocumentationManagementChapter9ProductionManagementChapter10QualityControlandQualityAssuranceChapter11ContractManufactureandAnalysisChapter12...
2.4InternalAudits(SelfInspection) 2.4内部审计(自检) 2.5ProductQualityReview 2.5产品质量审核 3.PERSONNEL 3.人员 3.1PersonnelQualifications 3.人员的资质 3.2PersonnelHygiene 3.2人员卫生 3.3Consultants 3.3顾问 4.BUILDINGSANDFACILITIES 4.建筑和设施 4.1DesignandConstruction ...
Internal Audits (Self Inspection) 内部审计(自检) To verify compliance with the principles of GMP for APIs, regular internal audits should be performed in accordance with an approved 为确实符合原料药 GMP 原则,应当按照批准的计划进行定期的内部审计。 schedule. Audit findings and corrective actions ...
14、ality control 第六章 质量控制 chapter 7 contract manufacturing and analysis 第七章 外包生产和样品分析 chapter 8 complaints and product recall 第八章 投诉和成品召回 chapter 9 self inspection 第九章 自检,13,eu guidelines to gmp欧洲gmp指南,annex 1 manufacture of sterile medicinal products 附录一...
The following cosmetic establishment instructions, excerpted from FDA's Inspection Operations Manual, may serve as guidelines for effective self-inspection. A good inspection score means that an establishment follows good manufacturing practice. 如果工厂严格的根据良好的操作规范(GMP)的要求生产,将最低限度的...
EU GMPs Chapter 9 – Self Inspection Principle ? Self inspections should be conducted in order to monitor the implementation and compliance with GMP principles and to propose necessary corrective measures. ? Personnel matters, premises, equipment, documentation, production, QC, distribution of the ...