1、 欧盟原料药GMP认证检查项目GMP Checklist for Active Pharmaceutical Ingredients (APIs)本GMP 认证检查项目基于法规要求和个人经验。This GMP checklist is based on regulatory requirements and personal experiences.I. 组织和人员Organization and PersonnelA质量部门责任Responsibilities of the Quality Unit (QU)企业...
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...
This GMP checklist is based on regulatory requirements and personal experiences. I. 组织和人员 Organization and Personnel A.质量部门责任 Responsibilities of the Quality Unit (QU) 企业应当建立独立的质量部门,质量部门应当参与所有与质量有关的活动 There should be a QU that is independent of production....
LeadAuditorpreparesInternalAudits’sscheduleatthebeginningofeachyear 审计负责人检查上次审计的结果状态。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,...
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...
5.502 Is the procedure for confirming vendor test results written and followed? Audit Checklist 6 Question Instructions/Questions Note any exceptions and comments in notebook Yes/No/NA 6.0 Operational Control 6.1 Material/Component/Label Verification, Storage, and Handling 6.101 §211.87 Do written...
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
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财产和符合性 Product Recall and Traceability 产品召回和可追溯性 Internal Audits内审 Business Planning业务应急计划 Sites and Facilities Management工厂和设施管理 Factory Facilities and Environment工厂设施和环境 Factory Equipment and Test Equipment 工厂的设备和测试设备 Foreign Contamination 异物污染 Product...
欧盟原料药GMP认证检查项目 GMP Checklist for Active Pharmaceutical Ingredients (APIs) 本GMP 认证检查项目基于法规要求和个人经验。 This GMP checklist is based on regulatory requirements and personal experiences. I. 组织和人员Organization and Personnel A.质量部门责任Responsibilities of the Quality Unit (QU)...