Agenda | ||
Opening 开会Meeting | ||
Monday, 22 March 2011 / 08:00 | ∙ Purpo of the audit and audit approach (by Lead Auditor)审计的目的和方式 ∙ Short Prentation on the plant: Company, Organization, Plant layout, Zone / Pressure concept, Personnel & Material flow for the manufacturing units公司简短的介绍，公司，组织机构，工厂布局，人事，生产材料流程 ∙ Agenda / Documentation prepared for the audit (e below)准备审计文件 | All |
Detailed Review 详细过程 | ||
08:30 – 10:00 | ∙ Document management system (version control, approval, and distribution of SOPs) 文件管理系统（版本控制，审批和分配的SOP） ∙ Job descriptions of key personnel关键人员的工作描述 ∙ Gowning procedures, medical check-ups无菌环境下的更衣流程，体检 ∙ Training system and records (Production and QC) 培训体系和记录 ∙ Internal and external audit program外部和内部审计计划 ∙ Supplier qualification供应商资质 | All |
10:00 – 13:00 | Plant tour:场地检查 ∙ Receiving areas ∙ Warehou, shipping operations ∙ cppccReturned and salvaged goods ∙ Sampling (incoming materials: methods, program) ∙ Storage of bulk and finished product ∙ Dispensing ∙ Archives (Batch records / Qualification records) ∙ Intermediate storage areas for bulk, printing materials and finished products ∙ Locker rooms for manufacturing personnel ∙ Production of sterile dosage forms (ampoules, vials) ∙ Equipment washing cabinets / facilities ∙ Packaging of facility ∙ Tool and maintenance work shops ∙ HVAC (AHUs) 现状分析∙ Water system ∙ Compresd air system •接收地区•仓库，运输业务，取样（来料，方法，程序），半成品和成品，批记录，印刷材料和成品储存区，生产人员的更衣室，设备洗涤，空调系统，水系统，压缩空气系统 | All |
13.00 – 17.00 | Analytical laboratory tour:分析实验室 ∙ Laboratory practices ∙ Preparation, labeling and handling of reagents ∙ Handling and management of product-, reference-, and retained samples ∙ Quality control raw data management, worksheets and records, archiving 补习班名字∙ Equipment qualification, maintenance and calibration ∙ Testing instructions, specifications, validation ∙ OOS/OOE procedure and documentation, review of OOS investigation reports, handling of discarded data ∙ Review of lected analytical batch records ∙ Stability program Microbiological Laboratory (if applicable) Packaging material laboratory (primary and condary incl. printed materials) •实验室的做法 killing•准备，标签及试剂处理 •产品的处理和管理，并保留样品 •质量控制管理的原始数据，工作表和记录，存档 •设备的资质，维修和校准 don jon•测试说明书，规格，验证 •OOS程序和文件，OOS调查报告 •审查选定的批检验记录 •稳定性试验 微生物实验室（如适用） 包装材料实验室 | All |
Tuesday, 22 March 2011 08:00 – 10:00 | Detail review of facilities and utilities:设施和设备 ∙ HVAC, qualification of all classified areas ∙ Cleanliness zoning concept ∙ Warehou, temperature mapping, monitoring ∙ Equipment qualification IQ, OQ, PQ ∙ Utilities (water system, compresd air), qualifi-cation and monitoring ∙ Preventive maintenance program ∙ Calibration program 空调净化系统和所有设备 洁净区 仓库，温度，监测 水系统，压缩空气 设备的IQ，OQ，PQ验证 校准程序 | All |
10.00 – 12.00 | ∙ Validation master plan & status overview of qualification and validation of facilities, equipment, computer systems ∙ Cleaning validation (concept, status, reports, quality risk asssment) ∙ Master cleaning records (equipment, rooms) ∙ Executed cleaning records, sanitization 验证总计划，设备设施资格审查，清洁验证（概念，现状，报告，风险评估），主清洁记录，消毒记录 | All |
13.00 – 15.00 | ∙ Master batch records (galenic and packaging) ∙ Executed batch records ∙ Reworking procedures (if applicable) ∙ Batch relea procedures and responsibilities ∙ Complaint handling (procedure and system) ∙ Periodic quality review reports (procedure) ∙ CAPA system, procedure ∙ Deviation handling (lected investigation reports and procedure) ∙ Batch rejection (procedure and list of rejected batches) ∙ 2013年研究生国家线模拟考Change control procedures and records ∙ Recall system. List of recalls and review of records 主批记录，返工程序，投诉处理，预防和纠正措施，偏差处理，拒绝放行的批，变更管理，召回制度 | All |
15:00 | Auditors’ Meeting (Preparation of exit meeting)审计官会议（准备退出会议） | |
Exit Meeting | ||
16:00 – 17:00 | ∙ Short introduction by Lead Auditor审计官简短介绍 ∙ Prentation of the audit obrvations审计建议 ∙ Respon / discussions讨论 ∙ Next steps including responsibilities & timeframes 接下来就是工作职责和时限 | All |
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