The checklist is a popular tool to assist the cGMP auditor in conducting a thorough, systematic and consistent audit.A checklist, however, should not be a substitute for proper planning and cooperative climate-setting prior to starting the audit. Consider the advantages of using a well-prepared c...
04-Basic GMP Audit Check List BASICGMP(GOODMANUFACTURINGPRACTICES)AUDITCHECKLIST 1.FACILITIESANDEQUIPMENT厂房/设备 BASICGMPREQUIREMENT/CRITERIAGMP要求/标准 1.工厂是否干净(评估的整个过程都要观察工厂清洁情况,工厂应该有定义清洁的环境要素并持续改善清洁状况).Isthe facilityclean(internal/external)?Throughoutthe...
Audit Checklist 1 Question Instructions/Questions Note any exceptions and comments in notebook Yes/No/NA 1.0 General Controls Does the facility and its many departments (organizational units) operate in a state of control as defined by the GMP regulations? 1.1 Organizational & Management Responsibi...
Prepare a checklist of the items to be audited based on cGMP’s, area procedures, etc. 1.3.4审计前,检查上一次审计的结果状态,以找出任何未完成的整改。 Before the audit, verify status of previous audits to address any open action 1.3.5执行审计,并将任何潜在的缺陷告知责任部门的管理人员。 Execut...
Audit Checklist for Drug Industry Disclaimer The following checklist is intended to aid in the systematic GMP audit of a facility that manufactures drug components or finished products. The adequacy of any procedures is subject to the interpretation of the auditor. Therefore, the author accepts no ...
LeadAuditorverifiesstatusofpreviousaudit.根据GMP和公司内部要求,审计负责人提供一份须检查项目/部门的清单。LeadAuditorprovidesachecklistoftheDepartmenttobeauditedbasedonGMP’s,departmentprocedures,etc在审计开始之前,审计负责人向被审计部门的经理提供内审计划。LeadAuditorprovidestheinternalAuditPlantotheManagerofthe...
编制Prepared /日期Date:批准Approved By/日期Date: SMP-QA04-R 3-02 启东东岳药业有限公司DONGYUE PHARMA 内审核查记录Internal Audit Checklist 日期Date 审核类型 Type 区域 Area 受审核部门 Audited Dept. 时间 Time 审核员 Auditor 受审核人员 Audited Personnel 条款号 Items 条款内容Contents(*关键项目Critical ...
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
FROM 15 minutes, 41 seconds read GET STARTED FOR FREE Ready for action? Start a free trial today! Free Trial BOOK Digital Checklists and Routines Standardize, Automate, and Action Operational Routines and Checklists View Chapters
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和政策、cGMP和产品...