02-欧盟检查流程

第第22节节--欧盟药品检查流程欧盟药品检查流程第第22节节--欧盟药品检查流程欧盟药品检查流程 The Inspection Process the compliance group Stan O'Neill 5 Stages of the Inspection Process5 Stages of the Inspection Process 检查的五个阶段检查的五个阶段 5 Stages of the Inspection Process5 Stages of the Inspection Process 检查的五个阶段检查的五个阶段 • STAGE 1 Reasons for carrying out an Inspection • 阶段1 进行检查的原因 • STAGE 2 Scheduling an Inspection • 阶段2 制定检查进度 • STAGE 3 Preparing for an Inspection • 阶段 3 检查的准备 • STAGE 4 Carrying out an Inspection • 阶段4 进行检查 • STAGE 5 Reporting on an Inspection • 阶段 5 写检查 报告 软件系统测试报告下载sgs报告如何下载关于路面塌陷情况报告535n,sgs报告怎么下载竣工报告下载 Stage 1 Stage 1 第一阶段第一阶段Stage 1 Stage 1 第一阶段第一阶段 REASONS FOR CARRYING OUT AN INSPECTION 进行检查的原因进行检查的原因 Reasons for carrying out an inspectionReasons for carrying out an inspection 进行检查的原因进行检查的原因 Reasons for carrying out an inspectionReasons for carrying out an inspection 进行检查的原因进行检查的原因 1. Applications received • New Licence/Approval applications • Technical Variation applications • Licence /Approval renewal applications 1. 受理申请 • 收到新许可证/批准申请 • 技术变更申请 • 许可证/批准更新申请 Reasons for carrying out an inspectionReasons for carrying out an inspection 进行检查的原因进行检查的原因 Reasons for carrying out an inspectionReasons for carrying out an inspection 进行检查的原因进行检查的原因 • 2. Re-inspections required – Existing Licence/Approval holders – Corrective action monitoring • 2.需要进行再检查 – 现有许可证/批件持有人 – 监督纠正措施 Reasons for carrying out an inspectionReasons for carrying out an inspection 进行检查的原因进行检查的原因 Reasons for carrying out an inspectionReasons for carrying out an inspection 进行检查的原因进行检查的原因 3. Notification Received • Changes to operations /dosage forms • Facility Upgrade 3. 收到通知 • 操作/剂型的变更 • 设备更新/升级 Reasons for carrying out an inspectionReasons for carrying out an inspection 进行检查的原因进行检查的原因 Reasons for carrying out an inspectionReasons for carrying out an inspection 进行检查的原因进行检查的原因 4. Requests received – An inspector – Another department of the Agency – The competent authority of another PIC or EU/EMEA Member State or MRA partner for an inspection report 4. 收到请求 – 一名检查员的要求 – 监管机构中另一个部门的要求 – 药品检查条约或欧盟/EMEA成员国或检查互认国 主管机构的要求，协助完成检查报告 Stage 2 Stage 2 第二阶段第二阶段Stage 2 Stage 2 第二阶段第二阶段 SCHEDULING AN INSPECTION 预先制定好检查计划 The Inspection Scheduling ProcessThe Inspection Scheduling Process 制定检查计划制定检查计划 The Inspection Scheduling ProcessThe Inspection Scheduling Process 制定检查计划制定检查计划 • Categories of inspections scheduled • 不同类型的检查计划 – Existing Licence /Approval Holders –现有许可证/批准件的持有人 – New Licence Applicants (prior to start- up) –新许可证申请人 (在投产前) • Risk Assessment used for Inspection scheduling • 对预期的检查计划进行风险评估 – Type of products manufactured 所生产产品的类型 – Volume of production 产量 – Result of previous Inspection(s) 以前检查的结果 – Product recalls since the last inspection 自上次检查 后发生的产品召回事件 – Product defects since the last inspection 自上次检查 后存在的产品缺陷 – Results of product testing programme 产品 检测 工程第三方检测合同工程防雷检测合同植筋拉拔检测方案传感器技术课后答案检测机构通用要求培训 的 结果 The Inspection Scheduling ProcessThe Inspection Scheduling Process 制定检查计划制定检查计划 The Inspection Scheduling ProcessThe Inspection Scheduling Process 制定检查计划制定检查计划 • Risk Assessment cont’d. 风险评估(续) – Enforcement reports impacting on the facility – 要求强制执行的报告对工厂的影响 – Adverse comments received from other agencies or bodies – 其他监管机构或团体所作的不良 评价 LEC评价法下载LEC评价法下载评价量规免费下载学院评价表文档下载学院评价表文档下载 – Significant changes within the company – 企业内的重大变更 The Inspection Scheduling ProcessThe Inspection Scheduling Process 制定检查计划制定检查计划 The Inspection Scheduling ProcessThe Inspection Scheduling Process 制定检查计划制定检查计划 – Request from overseas agencies – 国外监管机构的要求 – Variation Request where inspection deemed necessary – 对变更申请有必要进行的检查 – Significant queries arising from assessment of PA applications – 对批准前申请评估时提现的各种主要质疑 The Inspection Scheduling ProcessThe Inspection Scheduling Process 制定检查计划制定检查计划 The Inspection Scheduling ProcessThe Inspection Scheduling Process 制定检查计划制定检查计划 – Lists all facilities for inspection – 列出所有需要检查的厂房和设施 – Based on risk assessment – 根据风险评估的结果 – Dynamic document – 动态的文件及记录 – Revised from time to time as required – 按要求经常进行修订的文件 – Forms part of the Quality System – 质量体系的各种表格和内容 The Inspection Scheduling ProcessThe Inspection Scheduling Process 制定检查计划制定检查计划 The Inspection Scheduling ProcessThe Inspection Scheduling Process 制定检查计划制定检查计划 – Prepared by the Planning Manager – 检查计划由计划主管制定 – Identifies a 3-6 monthly schedule of Inspections – 制定一份为期3-6个月的检查计划 – Identifies the responsible inspector(s) – 指定检查级长 • Ongoing objective 检查目标 – inspection of manufacturing facilities every 2 years, wholesale facilities every 3 years – 生产工厂每2年检查地次，销售商每3年检查一次 The Inspection Scheduling ProcessThe Inspection Scheduling Process 制定检查计划制定检查计划 The Inspection Scheduling ProcessThe Inspection Scheduling Process 制定检查计划制定检查计划 Inspection notification Inspection notification 检查通知检查通知Inspection notification Inspection notification 检查通知检查通知 • Announced Inspections – Notification 2-4 weeks prior to inspection – Q.P. /Responsible Person is notified – Proposed inspection dates – Duration of the inspection (2-5 days) • 检查通知 – 提前2-4周发出检查通知 – 通知产品放行人 – 建议的检查日期 – 检查持续时间 (2-5 天) Inspection notification Inspection notification 检查通知检查通知Inspection notification Inspection notification 检查通知检查通知 • Unannounced Inspections – Grounds for suspicion – Significant number of deficiencies identified during a previous inspection • 未加通知的检查 – 存有怀疑 – 在以前检查中发现大量缺陷 Stage 3 Stage 3 第三阶段第三阶段Stage 3 Stage 3 第三阶段第三阶段 PREPARING FOR AN INSPECTION 检查的准备 Preparing for an Inspection Preparing for an Inspection 检查的准备检查的准备Preparing for an Inspection Preparing for an Inspection 检查的准备检查的准备 • Site Master File 工厂主文件 – PIC/S Document PH 4/93 – PIC/S 文件 PH 4/93 • Request additional information from the company • 要求企业提供补充资料 • Review of previous inspection issues and their resolution • 回顾审核以前检查到的问题和解决 方案 气瓶 现场处置方案 .pdf气瓶 现场处置方案 .doc见习基地管理方案.doc关于群访事件的化解方案建筑工地扬尘治理专项方案下载 • Review of any other relevant information relating to the company • 检查所有与企业相关的资料 • Prepare the Inspection Plan • 制定检查计划 • Request company to have certain documents available • 要求企业准备检查某些必需的文件 Preparing for an Inspection Preparing for an Inspection 检查的准备检查的准备Preparing for an Inspection Preparing for an Inspection 检查的准备检查的准备 Stage 4 Stage 4 第四阶段第四阶段Stage 4 Stage 4 第四阶段第四阶段 Carrying out a GMP/GDP inspection 进行 GMP/GDP检查 Carry out an Inspection Carry out an Inspection 进行检查进行检查Carry out an Inspection Carry out an Inspection 进行检查进行检查 • Arrival at the facility 到达工厂 – Warrant to inspect 受权检查 • Opening Meeting 召开会议 – Outline the purpose and scope of the inspection 概述检查目的和检查范围 – PA file review 审核批准前申报文件 – Identify some of the documentation which may be required during the inspection – 确定检查中可能需要审核的文件 – Licence review 审核许可证 Carry out an Inspection Carry out an Inspection 进行检查进行检查Carry out an Inspection Carry out an Inspection 进行检查进行检查 • Company Presentation – Brief, Succinct and Focused – Outline changes since the last inspection • 公司介绍 – 简明扼要，重点突出 – 概述自上次检查后所作的变更 The Inspection Plan The Inspection Plan 检查计划检查计划The Inspection Plan The Inspection Plan 检查计划检查计划 • Prepared by inspectors prior to the inspection • 在检查前，由检查员制定 • Brief outline will be given during the opening meeting • 在开幕式会议上作简要说明 • A typical inspection will include a plant visit and documentation review • 检查通常包括参观车间和检查文件 The Inspection Plan The Inspection Plan 检查计划检查计划The Inspection Plan The Inspection Plan 检查计划检查计划 • Company requests • 企业的要求 • Subject to change depending on inspection findings • 根据检查结果提出变更 • Not provided to the company • 检查计划不提供给公司 Key review areas Key review areas 关键的检查点关键的检查点Key review areas Key review areas 关键的检查点关键的检查点 • Process Validation 工艺验证 • Cleaning Validation 清洁验证 • Change Control 变更控制 • Customer Complaints 客户投诉 • Product Recalls 产品召回 • Rejected Batches 不合格批次 • Deviations 偏差 • OOS 超标结果 • Product Sampling 产品取样 – Routine 常规 – Spontaneous 随机 Review adequacy and appropriateness of actions taken 检查采取的措施是否 充分、适当 General Inspection Issues General Inspection Issues ––一般检查事项一般检查事项General Inspection Issues General Inspection Issues ––一般检查事项一般检查事项 1. Provision of documents requested 根据要求，提供文件 2. Question Answering 答疑 -- Informative, Factual and Concise --实用、真实、简洁 3. Deficiencies 缺陷 --Potential non-compliances 潜在的不符合事项 --Non-compliances 不符合事项 4. Proposed Corrective Actions 建议的纠正措施 Wrap up meeting Wrap up meeting 总结会议总结会议Wrap up meeting Wrap up meeting 总结会议总结会议 • Attendance 出席人员 • - Senior Management, Key technical personnel,Q.P. /Responsible Person, others 高级主管、关键技术人员、质量负责人/Q.P.等 • Summary of Deficiencies 缺陷总结 • - Resolved Deficiencies 已解决的缺陷 • - Classification of Deficiencies 缺陷级别 • - Categorisation of Deficiencies 缺陷分类 • Receipt of Samples requested 取样记录 • - Analytical Method, Reference Standard 分析方法、参考 标准 excel标准偏差excel标准偏差函数exl标准差函数国标检验抽样标准表免费下载红头文件格式标准下载 Stage 5 Stage 5 第五阶段第五阶段Stage 5 Stage 5 第五阶段第五阶段 Reporting on an inspection 写检查报告 Reporting on an inspection Reporting on an inspection 撰写检查报告撰写检查报告 Reporting on an inspection Reporting on an inspection 撰写检查报告撰写检查报告 The Inspection Report 检查报告 • Issued within 4 weeks after completion of the inspection • 应在完成检查后的4周内发出（检查报告） • Non-compliances identified • 明确缺陷项 • Points Requiring Clarification or Confirmation and Points to be Noted as appropriate will be reported • 应报告要求澄清或确认的问题及需注意的事项 • Standard EU format for GMP Inspection Reports • 采用欧盟GMP检查报告的标准格式 • Reply by Date (typically 4 weeks) • 要求对检查报告反馈意见日期(通常为4周) Reporting on an inspection Reporting on an inspection 撰写检查报告撰写检查报告 Reporting on an inspection Reporting on an inspection 撰写检查报告撰写检查报告 Company Response Company Response 企业的回复企业的回复Company Response Company Response 企业的回复企业的回复 • Format of the Response 答复有模板/标准格式 – Restate Observation 重申缺陷 – Include any comment/clarification – 包括所有的说明/澄清意见 – Set out details of the corrective action/proposed corrective action – 阐述纠正措施/提议的纠正措施的细节 – Set out the timetable for implementation of the corrective action – 制定出实施纠正措施的时间表 • Impact of deficiencies on other areas • 缺陷对其他环节的影响 • Response Review • 应对回复意见进行回顾检查 • 2 rounds of correspondence • 应进行2次沟通 Company Response Company Response 企业的回复企业的回复Company Response Company Response 企业的回复企业的回复 Inspection FollowInspection Follow--up up 检查的跟踪检查的跟踪Inspection FollowInspection Follow--up up 检查的跟踪检查的跟踪 • Recommendations to Executive Committee • 对常务委员会的建议 • Application Approval (issue, variation or renewal) • 申请的批准（发布、变更或更新） • Application Rejection (issue, variation or renewal) • 申请的拒绝（发布、变更或更新） • Suspension or Revocation (Existing licence or approval holder) • 中止或撤销（现许可证持有人或获得批件的人） • Reply to requests received • 对收到各种要求作出答复 • Inspection Schedule Update • 更新检查计划 • Recommended interval for re-inspection • 确定再检查的间隔时间 Inspection FollowInspection Follow--up up 检查的跟踪检查的跟踪Inspection FollowInspection Follow--up up 检查的跟踪检查的跟踪