文档介绍：1 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 pliance 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 ponents in the formulation 处方成份 2 BE information 生物等效性信息 3 Etc. 其它 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 1 Potency/purity 效价/ 纯度 2 Impurity profile (related substances) 3 杂质分布曲线图(相关物质) 4 Content uniformity 含量均匀度 5 Weight variation 重量差异 6 Dissolution profile 溶出曲线 7 Disintegration time 崩解时间 8 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 1 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 2 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) 3 API characterization and qualification, including chemical and physical properties studies, such as solubility, density, particle