文档介绍：Generic Drug Product Development Stages
仿制药发展阶段
(Oral Solid Dosage Forms, Tablets)
（口服固体制剂，片剂）
Stage
Chemistry, Manufacturing & Controls
in
Oral Solid Dosage Form Development
口服固体制剂发展中的化学特性，生产和控制
CGMP Compliance
to Meet
Regulatory Requirements
满足法规要求的CGMP规范
1
Drug Packaging Insert Study to obtain basic information about RLD, such as
通过对对照药物的包材以内成分的分析，获取有关该对照药物的基本信息
Components in the formulation处方成份
BE information生物等效性信息
2
Reverse Engineering Study, including evaluation of three different lots of RLD for:
根据前述研究采用倒推法研究制剂工艺，包括对叁批不同批次对照药物的评估
Potency/purity 效价/纯度
Impurity profile (related substances)
杂质分布曲线图（相关物质）
Content uniformity 含量均匀度
Weight variation 重量差异
Dissolution profile 溶出曲线
Disintegration time 崩解时间
Hardness and Friability 硬度和脆碎度
System based CGMP auditing on manufacturing facility:
① Quality System
② Materials System
③ Facilities and Equipment System
④ Production System
⑤ Packaging and Labeling System
⑥ Laboratory Control System
对生产设施进行基于系统的CGMP审计
① 质量系统
② 物料系统
③ 设施设备系统
④ 生产系统
⑤ 包装和标签系统
⑥ 实验室控制系统
3
Pre-formulation Studies
处方前研究
Analytical method development分析方法发展
(Develop adequate analytical methods for API)
针对原料药发展合适的分析方法
Acquiring API and related impurity reference standards (USP or other sources)获得原料药和相关杂质参考标准（美国药典或其他来源）
API characterization and qualification, including c