Question

求高手翻译！！！~~~~不要翻译器的

Water Purification, Storage, and Distribution for Pharmaceutical Production

Areas and Facilities Cleaning and Maintenance

Preventative Maintenance

Global Tablet Press Tooling

Transfer of Analytical Methods

Foreign Matter Control, Testing and Inspecting of Sterile Products

Laboratory Management

Use and Control of Laboratory Reagents and Reference Standards

Evaluation and Investigation of Trace Unidentified Chromatographic Peaks

Verification of Compendial Analytical Methodology

Use Non-Registered Analytical Method

Raw Materials and Packaging Materials: Receipt

Sampling of Production Materials and Finished Goods

Batch and Lot Identification

Metal Detection

Inspecting for Manufacturing and Packaging Defect – Aseptic

Control of Manufacturing and Packaging Defects Non-Sterile

Receipt, Approval, and Use of Labels and Labeling

Documentation Practices

Disposition of Production Materials and Finished Products

Quality Assurance Self-Appraisals (QASA)

Returned Goods

Document Retention

Validation of Analytical Methods for Equipment Cleaning

Validation Requirements and Documentation

Analytical Methods Validation

Laboratory Equipment Qualification

Answer 1

好多的~~
Water Purification, Storage, and Distribution for Pharmaceutical Production
水的净化，存储和药品生产的分配
Areas and Facilities Cleaning and Maintenance
公共场所和设施的清洁与维修
Preventative Maintenance
防护检修
Global Tablet Press Tooling
全球压片机模具
Transfer of Analytical Methods
分析法的转移
Foreign Matter Control, Testing and Inspecting of Sterile Products
无菌药品的杂质控制，测试和检验
Laboratory Management
实验室管理
Use and Control of Laboratory Reagents and Reference Standards
实验室试剂和参考标准的使用和控制
Evaluation and Investigation of Trace Unidentified Chromatographic Peaks
不明色谱峰的评估和调查
Verification of Compendial Analytical Methodology
简明分析方法的验证
Use Non-Registered Analytical Method
使用不记名（不注册）的分析方法
Raw Materials and Packaging Materials: Receipt
原材料和包装材料：收据
Sampling of Production Materials and Finished Goods
生产材料和制成品的取样
Batch and Lot Identification
批号和批次识别鉴定
Metal Detection
金属探测法
Inspecting for Manufacturing and Packaging Defect – Aseptic
对生产和包装缺陷-防腐剂的检测
Control of Manufacturing and Packaging Defects Non-Sterile
对生产和包装缺陷非无菌的控制
Receipt, Approval, and Use of Labels and Labeling
收据，批准以及标签和标注的使用
Documentation Practices
文件实际操作
Disposition of Production Materials and Finished Products
生产材料和制成品的配置
Quality Assurance Self-Appraisals (QASA)
质量保证 自我评估
Returned Goods
退货
Document Retention
档案保管
Validation of Analytical Methods for Equipment Cleaning
分析方法和设备清洁的验证
Validation Requirements and Documentation
验证，要求和档案
Analytical Methods Validation
分析方法验证
Laboratory Equipment Qualification
实验室设备验证
尽力了，供您参考。

Answer 2

不会

Answer 3

药品生产的水质、仓储和物流
地面及设施的清洁和维护
预防性维护
全球压片机
分析方法的转换
异物的控制，无菌产品的检验和检测
实验室管理
实验室试剂和参考标准的使用和控制
不明色谱峰的评估和追踪调查
药典分析方法的验证
使用非注册的分析方法
原材料及包装材料收据
生产材料和成品的抽样
批次和批号
金属检测
制造及包装缺陷 - 无菌检查
制造业和非无菌包装缺陷的控制
收据，审批和使用的标签和标识
文档实践
生产材料和成品的处置
质量保证自我评估（QASA）
退换商品

文档保留

设备清洗的分析方法验证

审定要求的文档

分析方法验证

实验室的设备资格