AN3) Change in the code product/reference number and/or in the brand name of the final substance or any material used in its manufacture (former N9)
Condition:
- the change does not regard the quality of the final substance or the concerned material
Specific Documentation:
- approved and proposed code product / reference number / brand name
AN3 原料药或生产过程使用的任一物料的产品代码或索引号或商标名变更(以前的N9)
条件:
- 变更与原料药质量或相关的物料质量无关
文件要求
- 产品代码、索引号、商标名新旧对照表
AN4) Minor change in the manufacturing process of the final substance (former R1)
Conditions:
- the specifications of the final substance or intermediates are unchanged and there is no adverse change in qualitative and quantitative impurity profile
- the synthetic route remains the same, i.e. intermediates remain the same and there are no new reagents, catalysts or solvents used in the process. In the case of herbal products, the geographical source and production of the herbal material remain unchanged
- the final substance is not a biological substance.
Specific Documentation:
- batch analysis data (in comparative tabular format) of at least two batches (minimum pilot scale) manufactured according to the currently approved and proposed process.
AN4 原料药生产工艺的微小变化(以前的R1)
条件:
- 原料药或中间体标准不变,并且定性、定量的杂质概况均没有不利的变化
- 合成途径未变,即:中间体不变,而且工艺中未用到新试剂、催化剂或溶剂。对于植物制剂产品,其地理来源及生产操作不变
- 原料药不是生物制品
文件要求
- 工艺变动前后至少两个批号产品的批分析数据(对比表格) (至少应为中试批)