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T-01-QUAL T-02-QUAL T-03-QUAL T-04-QUAL T-05-QUAL T-06-QUAL T-07-QUAL T-08-QUAL T-09-QUAL T-10-QUAL T-11-QUAL T-12-QUAL T-13-QUAL T-14-QUAL T-15-QUAL
QA-01-VAL QA-02-VAL QA-03-VAL QA-04-VAL QA-05-VAL QA-06-VAL QA-07-VAL QA-08-VAL
研发R & D 试生产管理Trial Production Management 研发项目管理和文件控制R&D Project Management and Document Control 实验室药品和仪器的管理Regulation for Reagent and Instrument Management
QA-09-VAL
文件名称Document Name
质量手册Quality Manual 质量手册Quality Reference Manual
生产部－车间和仓库Production - Warehouse & Workshop 原料批号的管理规定Assigning Batch Numbers to Raw Materials 散装化学原料的处理和取样程序Handling and Sampling Bulk Materials 原料或包装材料接收和贮存程序Procedure for Receipt and Storage of Raw Materials or Packaging Materials 仓库送料到生产车间程序Procedure for Delivering Raw Materials to Production 洁净室、QC实验室和仓库环境监测Clean Room, QC Laboratory and Warehouse Environmental Monitoring 成品接收、贮存管理Procedure for Receipt and Storage of Final Product 物料有效期的监控Procedure for Monitoring Materials Shelf Life 产品和回收溶剂批号分配Assigning Batch Number to Products & Recovered Solvent 生产区的卫生Sanitation in Production Areas 设备和管线标识Labeling of Equipment and Transfer Lines 物料编号系统Material Code System 用具的使用、清洁和贮存程序GMP UTENSILS - USE, CLEANING AND STORAGE PROGRAM 洁净区的标准操作规范Good Operation Practice of FTU 防虫害管理Pest Control 生产计划管理 Manufacturing Order Control 中间体仓库管理制度Intermediate Warehouse Administration System 仓库的卫生Sanitation of Warehouse 操作过程中交叉污染的预防Cross Contamination Prevention of Operations 中间产品的标识Labeling Work In Process Material 成品销售前的贴签Labeling finished products for sale 工艺用水的监控和使用Process Water Monitoring and Using 生产车间管理制度General Regulation for Production Areas 1250工艺规程 Manufacturing Procedure for 1250 1320工艺规程 Manufacturing Procedure for 1320 纯化水的制备和储存Preparation and Usage of purified water 过滤袋的制作和使用管理Regulation of preparation and usage of filter bag 危险剧毒品存放和使用出库手续管理规定Special Dangerous Goods Storage and Take Out Procedure 设备清洗程序Equipment Checking Procedure
编号 Doc.No.
---
P-01 P-02 P-03 P-04 P-05 P-06 P-07 P-08 P-09 P-10 P-11 P-12 P-13 P-14 P-15 P-16 P-17 P-18 P-19 P-20 P-21 P-22 P-23 P-24 P-25 P-26 P-27 p-28
S-01 S-02 S-03
质量手册Quality Manual 生产部－车间和仓库Production - Warehouse & Workshop
采购和销售Βιβλιοθήκη Baidu质量保证QA
QA-01 QA-02 QA-03 QA-04 QA-05 QA-06 QA-07 QA-08 QA-09 QA-10 QA-11 QA-12 QA-13 QA-14 QA-15 QA-16 QA-17 QA-18 QA-19 QA-20 QA-21 QA-22 QA-23 QA-24
人事部H&R 培训程序Training Program 员工健康管理 Staff Health Management Policy 部门职责Resposibility of Departments
技术部Technical 建 (构) 筑 物 维 护 制 度Building Maintenance Regulation 洁净室设备维修制度Equipment Maintenance Regulation In FTU 压力容器安全管理制度Pressure Vessel Management Regulation 计量器具校验制度Measuring Instrument Calibration Regulation 设备维修保养制度Equipment maintenance regulation 设备大修管理制度Equipment overhaul regulation 设备巡回检查制度Routine inspection regulation 设备润滑制度Equipment lubrication regulation 设备密封管理制度Equipment sealing up regulation 设备事故管理制度Equipment accident management regulation 玻璃系统安装程序Glass system Installation procedure 空气净化系统维修规程Maintenance Procedure of HVAC system FTU 空气净化系统操作规程SOP for air cleaning system 电气安全操作程序Electrical Work Safety Procedure 导热油系统安全操作规程safety SOP Thermo oil system 氢气、氮气、压缩空气钢瓶安全操作规程SOP For Hydrogen, Nitrogen And Compressed Air Cylinder 设备内部作业安全工作程序Safe operation procedure Confined Space equipment 真空滚动干燥器操作规程Operation Procedure of Vacuum Tumble Dryer
自动滴定仪操作规程SOP for Potentiometer 紫外分光光度计操作规程Sop For UV-Visible Spectrophotometer PH计操作规程SOP FOR pH METE 阿贝折射仪操作规程SOP FOR ABBE REFRACTOMETER 气相色谱仪操作规程SOP FOR GC 高效液相色谱仪操作规程PROCEDURE FOR HPLC Shimadzu HPLC操作规程SOP FOR Shlmadzu HPLC QC检验、记录、复验制度QC Dept. TEST, RECORD & RETEST SYSTEM 化验室卫生及安全规范LABORATORY HYGIENE AND SAFETY OPERATION 稳定性考察管理制度MANAGEMENT OF STABILITY MONITORING 稳定性考察操作规程SOP FOR STABILITY MONITORING 中控标准及检验方法In-process Control Limit and Test Methods 原料、中间产品、成品、包装材料的质量标准和分析方法Specifications and test methods for Raw Materials, Intermediates, Finished Products and Packaging Materials 通用检测方法General Test Methods 旋光仪操作规程SOP for Polarimeter
QA-25
R-01 R-02 R-03
QC-01 QC-02 QC-03 QC-04 QC-05 QC-06 QC-07
研发R & D 质量控制QC
QC-08 QC-09 QC-10 QC-11 QC-12 QC-13 QC-14 QC-15 QC-16 QC-17 QC-18 QC-19 QC-20 QC-21 QC-22
质量控制QC 取样制度及规程Sampling Management and Procedure 留样管理制度Management of Reserve Sample 留样操作规程SOP for Handing Reserve Sample 检验试剂管理制度Reagent Management 检验试剂SOP Reagent SOP 分析仪器管理制度Analytical Instrument Management 电子分析天平标准操作规程SOP for Electronic Balance
H-01 H-02 H-03
T-01 T-02 T-03 T-04 T-05 T-06 T-07 T-08 T-09 T-10 T-11 T-12 T-13 T-14 T-15 T-16 T-17 T-18
人事部H&R 技术部Technical
T-19 T-20 T-21 T-22 T-23 T-24 T-25 T-26 T-27 T-28 T-29 T-30 T-31 T-32
采购和销售 物料采购程序PURCHASING PROCEDURE 成品销售程序Shipping Procedure 销售制度和用户访问制度REGULATION FOR SALES AND CUSTOMER SERVICE
质量保证QA
不确定原料的放行程序Acceptance of Nonconforming Raw Material 文件控制程序Document Control Procedure 变动控制程序Change Control Procedure 偏差处理程序Documentation and Justification of Deviation 质量体系内部审核和检查Internal Audit and Inspection by Quality Assurance 客户投诉和不良反应报告处理Procedure for Handling Customer Complaint and ADR Report 销售标签使用制度Sales Label Usage Regulation 产品退货/召回Product Return/Recall Procedure 合格供应商评定程序Establishment of Approved Supplier List 批记录审核Batch Record Review 生产工艺规程的控制程序Document Control Procedure for Product Master Files 批档案的文件管理Document Control for Batch Records 工艺验证程序 Process Validition 质量调查Quality Assurance Investigation 纠正措施管理Regulation for Corrective Action 超出质量标准范围产品的处理程序Procedure for Checking of out of specification material SOPs的建立程序Establishment of SOP 记录的书写要求Good Documentation Practice 质量档案 Annual Product Review 文件格式Standardisation of company documents 质量统计报告制度Quality Statistics Regulation 质量标准的建立程序Establishment of Specification 计量器具管理制度Measuring Instrument Management Regulation 委托检测的管理Management of Contract Testing 原料、包装材料、中间体和成品的放行程序 Release Procedure for Raw Material, Packaging Material, Intermediate and Final Product
QA-01-VAL QA-02-VAL QA-03-VAL QA-04-VAL QA-05-VAL QA-06-VAL QA-07-VAL QA-08-VAL
研发R & D 试生产管理Trial Production Management 研发项目管理和文件控制R&D Project Management and Document Control 实验室药品和仪器的管理Regulation for Reagent and Instrument Management
QA-09-VAL
文件名称Document Name
质量手册Quality Manual 质量手册Quality Reference Manual
生产部－车间和仓库Production - Warehouse & Workshop 原料批号的管理规定Assigning Batch Numbers to Raw Materials 散装化学原料的处理和取样程序Handling and Sampling Bulk Materials 原料或包装材料接收和贮存程序Procedure for Receipt and Storage of Raw Materials or Packaging Materials 仓库送料到生产车间程序Procedure for Delivering Raw Materials to Production 洁净室、QC实验室和仓库环境监测Clean Room, QC Laboratory and Warehouse Environmental Monitoring 成品接收、贮存管理Procedure for Receipt and Storage of Final Product 物料有效期的监控Procedure for Monitoring Materials Shelf Life 产品和回收溶剂批号分配Assigning Batch Number to Products & Recovered Solvent 生产区的卫生Sanitation in Production Areas 设备和管线标识Labeling of Equipment and Transfer Lines 物料编号系统Material Code System 用具的使用、清洁和贮存程序GMP UTENSILS - USE, CLEANING AND STORAGE PROGRAM 洁净区的标准操作规范Good Operation Practice of FTU 防虫害管理Pest Control 生产计划管理 Manufacturing Order Control 中间体仓库管理制度Intermediate Warehouse Administration System 仓库的卫生Sanitation of Warehouse 操作过程中交叉污染的预防Cross Contamination Prevention of Operations 中间产品的标识Labeling Work In Process Material 成品销售前的贴签Labeling finished products for sale 工艺用水的监控和使用Process Water Monitoring and Using 生产车间管理制度General Regulation for Production Areas 1250工艺规程 Manufacturing Procedure for 1250 1320工艺规程 Manufacturing Procedure for 1320 纯化水的制备和储存Preparation and Usage of purified water 过滤袋的制作和使用管理Regulation of preparation and usage of filter bag 危险剧毒品存放和使用出库手续管理规定Special Dangerous Goods Storage and Take Out Procedure 设备清洗程序Equipment Checking Procedure
编号 Doc.No.
---
P-01 P-02 P-03 P-04 P-05 P-06 P-07 P-08 P-09 P-10 P-11 P-12 P-13 P-14 P-15 P-16 P-17 P-18 P-19 P-20 P-21 P-22 P-23 P-24 P-25 P-26 P-27 p-28
S-01 S-02 S-03
质量手册Quality Manual 生产部－车间和仓库Production - Warehouse & Workshop
采购和销售Βιβλιοθήκη Baidu质量保证QA
QA-01 QA-02 QA-03 QA-04 QA-05 QA-06 QA-07 QA-08 QA-09 QA-10 QA-11 QA-12 QA-13 QA-14 QA-15 QA-16 QA-17 QA-18 QA-19 QA-20 QA-21 QA-22 QA-23 QA-24
人事部H&R 培训程序Training Program 员工健康管理 Staff Health Management Policy 部门职责Resposibility of Departments
技术部Technical 建 (构) 筑 物 维 护 制 度Building Maintenance Regulation 洁净室设备维修制度Equipment Maintenance Regulation In FTU 压力容器安全管理制度Pressure Vessel Management Regulation 计量器具校验制度Measuring Instrument Calibration Regulation 设备维修保养制度Equipment maintenance regulation 设备大修管理制度Equipment overhaul regulation 设备巡回检查制度Routine inspection regulation 设备润滑制度Equipment lubrication regulation 设备密封管理制度Equipment sealing up regulation 设备事故管理制度Equipment accident management regulation 玻璃系统安装程序Glass system Installation procedure 空气净化系统维修规程Maintenance Procedure of HVAC system FTU 空气净化系统操作规程SOP for air cleaning system 电气安全操作程序Electrical Work Safety Procedure 导热油系统安全操作规程safety SOP Thermo oil system 氢气、氮气、压缩空气钢瓶安全操作规程SOP For Hydrogen, Nitrogen And Compressed Air Cylinder 设备内部作业安全工作程序Safe operation procedure Confined Space equipment 真空滚动干燥器操作规程Operation Procedure of Vacuum Tumble Dryer
自动滴定仪操作规程SOP for Potentiometer 紫外分光光度计操作规程Sop For UV-Visible Spectrophotometer PH计操作规程SOP FOR pH METE 阿贝折射仪操作规程SOP FOR ABBE REFRACTOMETER 气相色谱仪操作规程SOP FOR GC 高效液相色谱仪操作规程PROCEDURE FOR HPLC Shimadzu HPLC操作规程SOP FOR Shlmadzu HPLC QC检验、记录、复验制度QC Dept. TEST, RECORD & RETEST SYSTEM 化验室卫生及安全规范LABORATORY HYGIENE AND SAFETY OPERATION 稳定性考察管理制度MANAGEMENT OF STABILITY MONITORING 稳定性考察操作规程SOP FOR STABILITY MONITORING 中控标准及检验方法In-process Control Limit and Test Methods 原料、中间产品、成品、包装材料的质量标准和分析方法Specifications and test methods for Raw Materials, Intermediates, Finished Products and Packaging Materials 通用检测方法General Test Methods 旋光仪操作规程SOP for Polarimeter
QA-25
R-01 R-02 R-03
QC-01 QC-02 QC-03 QC-04 QC-05 QC-06 QC-07
研发R & D 质量控制QC
QC-08 QC-09 QC-10 QC-11 QC-12 QC-13 QC-14 QC-15 QC-16 QC-17 QC-18 QC-19 QC-20 QC-21 QC-22
质量控制QC 取样制度及规程Sampling Management and Procedure 留样管理制度Management of Reserve Sample 留样操作规程SOP for Handing Reserve Sample 检验试剂管理制度Reagent Management 检验试剂SOP Reagent SOP 分析仪器管理制度Analytical Instrument Management 电子分析天平标准操作规程SOP for Electronic Balance
H-01 H-02 H-03
T-01 T-02 T-03 T-04 T-05 T-06 T-07 T-08 T-09 T-10 T-11 T-12 T-13 T-14 T-15 T-16 T-17 T-18
人事部H&R 技术部Technical
T-19 T-20 T-21 T-22 T-23 T-24 T-25 T-26 T-27 T-28 T-29 T-30 T-31 T-32
采购和销售 物料采购程序PURCHASING PROCEDURE 成品销售程序Shipping Procedure 销售制度和用户访问制度REGULATION FOR SALES AND CUSTOMER SERVICE
质量保证QA
不确定原料的放行程序Acceptance of Nonconforming Raw Material 文件控制程序Document Control Procedure 变动控制程序Change Control Procedure 偏差处理程序Documentation and Justification of Deviation 质量体系内部审核和检查Internal Audit and Inspection by Quality Assurance 客户投诉和不良反应报告处理Procedure for Handling Customer Complaint and ADR Report 销售标签使用制度Sales Label Usage Regulation 产品退货/召回Product Return/Recall Procedure 合格供应商评定程序Establishment of Approved Supplier List 批记录审核Batch Record Review 生产工艺规程的控制程序Document Control Procedure for Product Master Files 批档案的文件管理Document Control for Batch Records 工艺验证程序 Process Validition 质量调查Quality Assurance Investigation 纠正措施管理Regulation for Corrective Action 超出质量标准范围产品的处理程序Procedure for Checking of out of specification material SOPs的建立程序Establishment of SOP 记录的书写要求Good Documentation Practice 质量档案 Annual Product Review 文件格式Standardisation of company documents 质量统计报告制度Quality Statistics Regulation 质量标准的建立程序Establishment of Specification 计量器具管理制度Measuring Instrument Management Regulation 委托检测的管理Management of Contract Testing 原料、包装材料、中间体和成品的放行程序 Release Procedure for Raw Material, Packaging Material, Intermediate and Final Product