(a)oftheFD&CAct. Rigorousadherencetogoodmanufacturingpracticeminimizestheriskofadulterationormisbrandingofcosmetics.Thefollowingcosmeticestablishmentinstructions,excerptedfromFDA'sInspectionOperationsManual,mayserveasguidelinesforeffectiveself-inspection.Agoodinspectionscoremeansthatanestablishmentfollowsgoodmanufacturingpractice...
GMP现场检查Checklist(ENGLISH).doc,6.2 Addendum B:GMP Checklist for Compliance with GMP DIRECTORATE: INSPECTORATE and LAW ENFORCEMENT INSPECTOR’S CHECKLIST FOR ROUTINE GMP INSPECTION 6.3 Addendum C: Cover letter for GMP inspections SUB DIRECTORATE: MEDI
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...
as far as possible, that the medicinal products are stored, distributed and subsequently handled so that quality is maintained throughout their shelf life; there is a procedure for Self-Inspection and/or quality audit which regularly appraises the effectiveness and applicability of the Quality Assuran...
GMP内审体系指引 I. 目的 PURPOSE:建立一个DXC GMP内审的体系，保证企业的运行符合cGMP的要求。To establish an DXC GMP internal audit’s system to make sure all operations in DXC T.O are in compliance with the cGMP.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...
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...
25、isation operationssite:process location:process identification:the questions are grouped into three audit/inspection levels (al) depending on the type of audit/inspection undertaken:due diligence = level 1 questionsstandard = levels 1 + 2 questionsinternal site self inspection = all questionsaq =...
1 0 MAIN AUDIT METHODS 主要审核方式 Management staff interview管理人员访谈 On-site inspection现场审核 Document review文件审核 Workers interview, focus on warehouse person, inspectors, production persons, etc. 工人访谈, 主要关注仓 库人员,检验人员,生产人员等。 1 1 Section of Checklist检查表模块...
14、样品要求Test Reports19 试验报告Test Labs.19试验室Off-the-shelf Audits20 现有审核报告Surveys & General Information.20 调查和一般信息Quality Systems Audits.20 质量体系审核Product Integrity Contacts.22 产品完整性联系方式Quality Systems Audit Self-Assessment Checklist.23 质量体系审核自我评估一览表BV Tes...
6.4 In-Process Inspection, Sampling, and Laboratory Control 6.401 §211.110(a) Are written procedures established to monitor output and validate the performance of manufacturing procedures that may cause variability in characteristics of in-process materials and finished drug products? 6.402 §211.110(c...