这个需要按照重大变更报CDE进行补充申请，监管机构批准后方可进行。但往往，这类的变更是不会批准的。

需要根据你的工艺控制策略来确定的，如果你的中间体质量标准数据比较稳定，且工艺参数可以间接或直接反应该数据的稳定性，可以通过收集一定批次的数据进行评估，并通过变更控制来减少控制指标。

你的工艺信息表里面有中间体检测，如果评估确实有依据去掉，需要到根据情况去备案或者补充申请。见变更指导原则：放宽或删除已批准的起始原料、中间体质量控制和生产过

程控制，可能导致原料药的杂质谱、关键理化性质发生变化的，需要补充申请。

ICH Q7中有说法：

可以参考下列原则来缩检。

7.3 Sampling and Testing of Incoming Production Materials

 7.30 At least one test to verify the identity of each batch of material should be conducted, with the exception of the materials described below in 7.32. A supplier's Certificate of Analysis can be used in place of performing other tests, provided that the manufacturer has a system in place to evaluate suppliers. 

 7.31 Supplier approval should include an evaluation that provides adequate evidence (e.g., past quality history) that the manufacturer can consistently provide material 16 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients meeting specifications. Full analyses should be conducted on at least three batches before reducing in-house testing. However, as a minimum, a full analysis should be performed at appropriate intervals and compared with the Certificates of Analysis. Reliability of Certificates of Analysis should be checked at regular intervals. 

 7.32 Processing aids, hazardous or highly toxic raw materials, other special materials, or materials transferred to another unit within the company’s control do not need to be tested if the manufacturer’s Certificate of Analysis is obtained, showing that these raw materials conform to established specifications. Visual examination of containers, labels, and recording of batch numbers should help in establishing the identity of these materials. The lack of on-site testing for these materials should be justified and documented. 

 7.33 Samples should be representative of the batch of material from which they are taken. Sampling methods should specify the number of containers to be sampled, which part of the container to sample, and the amount of material to be taken from each container. The number of containers to sample and the sample size should be based upon a sampling plan that takes into consideration the criticality of the material, material variability, past quality history of the supplier, and the quantity needed for analysis. 

 7.34 Sampling should be conducted at defined locations and by procedures designed to prevent contamination of the material sampled and contamination of other materials. 

 7.35 Containers from which samples are withdrawn should be opened carefully and subsequently reclosed. They should be marked to indicate that a sample has been taken.

不是太懂缩检具体是指什么。减少检测指标？

我们分两种情况来看，一种是未激活状态或者还处于研发阶段的原料药，那么通常中间体的指标或者质量标准还在研究、数据积累阶段，那么其实可能各个指标都是暂定的。也就不存在需要缩检的什么问题了。如果用于临床了，需要走相应的变更流程。

另外一种是已经是A状态或者已经商业化的原料药，那么可能已经监管的审核和背书，其质量标准，工艺规程自然都是确定的，通常是需要按照既定的程序去检测及放行。如果说需要变更，那么按照不同的变更等级去走变更。

原料药中间体也有质量标准，对于非关键项目可以基于以往检测评估后定期检测！