郑州Argos品质验厂审核清单 大连GMP认证要求

1.      Quality Manual (including quality policy, objectives, organization chart, job description, reference to / procedures for the Quality Management System)
品质手册（包括质量方针，质量目标，组织架构图，工作职责描述，及与品质管理体系相关的程序）                                                
2.      Management Review (procedure, agenda, report)
管理评审（程序，议题，报告）
3.      Internal audit documents (procedure, plan, audit report)
内审文件（程序文件，计划，评审报告）
4.      Supplier Control documents (supplier approval control procedure / criteria, list of approval supplier list, supplier evaluation records)
供应商管控文件（供应商评估控制程序/标准，合格供应商明细，供应商评估报告）
   
5.      Document Control procedure (including that for record keeping)
文件控制程序（包括记录文件）
6.      Inspection Specification / Instruction (including IQC, In-process, Final)
检验标准/指导（包括来料检验，制成检验及终检）
7.      Work Instruction for each manufacturing process
作业：所有生产工序的指导
8.      Procedure for definition and reporting of “incident”
事故定义及报告程序
9.      Product recall procedure
产品招回程序
10.    Customer complaints procedure and complaint records
客户投诉程序及记录
11.    Corrective Action reports (related to incident, internal audit, complaint, etc)
改善措施报告（与事故，内审及投诉等相关的）
12.    Test records on Traceability system
追溯体系的测试记录
   
13.    Equipment maintenance documents (plan, procedure, record)
设备保养文件（保养计划，保养程序及保养记录）
14.    Calibration of monitoring & measuring devices (plan, procedures, records)
监控及测量仪器的校验（计划，程序文件，记录）
15.    Written procedure for handling glass and hard clear plastic breakages Cleaning
    schedule and procedure
书面玻璃及利器管控程序和清理安排

16.    Waste handling / storage procedure or record
废品控制/存储程序及记录

17.    Pest control documents (list of trained pest control staff, contract with external pest control agency, pest control inspection record, bait documentation)
虫害控制文件（专业虫害控制人员名单，与外部虫害控制公司的合同书，虫害控制记录等）
  
18.    Process flow documentation
工艺流程文件
19.    Record / plan for “Hazard Analysis” of the entire production processes
全部流程的风险评估计划及记录
20.    Hazards Assessment records during product design and development
产品设计及开发过程中的风险评估记录
21.    Monitoring records of foreign body detectors (e.g. daily sensitivity records of metal detectors)
外来物品探测器（比如：每日金属探测记录）
22.    Broken needle procedure & records (if applicable)
断针控制程序及记录（如果适用）
23.    Sharp tool control procedure & records (if applicable)
利器控制程序及记录（如果适用）
24.    Nonconforming product control procedure
不良品控制程序
25.    Guidance on quantity checking
产品数量检查指导
26.    Approved reference samples
合格样品
27.    Control procedure for equipment failure and process deviation
不良仪器的管控程序及隔离控制

28.    Factory’s own training program (plan, procedure, records)
工厂内部的培训计划（计划，程序，记录）