Starting materials (API and excipients)

起始物料（API和辅料）

Material Safety Data Sheets

物质安全数据表

Product development report

产品开发报告

Storage conditions

储存条件

Stability data

稳定性数据

Forced stability data

强制稳定性数据

Specifications

标准

Supplier qualification

供应商确认

References

对照

Formulation

配方

Formulation development reports

配方开发报告

Master formula

主配方

Material compatibility/interaction studies

材料兼容性/相互作用研究

Batch manufacturing

批生产

Batch manufacturing document

批生产文件

Scale up information

放大信息

Risk assessment

风险评估

Critical process parameters In-process control specification

关键工艺参数过程控制标准

Scale up protocol and report

放大方案和报告

Process validation

工艺验证

Batch packaging

批包装

Packaging material specification

包装材料标准

Batch packaging document

批包装文件

Validation

验证

Finished product

成品

Specification

标准

Analytical procedures

分析方法

Analytical test procedures

分析测试程序

Analytical method development

分析方法开发

Analytical procedure validation

分析方法验证

Standard test procedures

标准测试程序

Instrument specifications

仪器规范

Quality control

质量控制

Sampling procedures (e.g. in-process control)

取样程序（例如，过程控制）

Stability testing protocol and procedures

稳定性测试方案和程序

Equipment and instruments

设备和仪器

List of equipment and instruments

设备和仪器列表

Calibration information

校准信息

Preventive maintenance information

预防性维护信息

Overview of qualification

确认情况概述

Cleaning

清洁

Overview of cleaning approach

清洁方法概述

Cleaning procedure development and cleanability

清洁程序开发和可清洁性

Cleaning procedures

清洁程序

Health Based Exposure Level (Permitted daily exposure) information  reports

基于健康的暴露水平（允许日暴露量，PDE）信息报告

Analytical procedures validation for cleaning validation sample analysis

清洁验证取样分析的分析方法验证

Other documents

其他文件

Rejected batch information

已拒绝批次信息

Bio-batch information

生物批次信息

Pilot batch information

中试批次信息

History of changes and change management

变更历史和变更管理

Hold time protocols and reports

保存时间方案和报告