温州之约问题问题集结;66.工艺规程中的原辅料清单上要列明所有辅料吗？

beiwei5du

列是应该列入的，不知道楼主最后对于“处方量”是怎么处理的呢？？下面的法规是否说明必须对每个物料都要定量呢？？？？
选自：EU GMP
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/chapter4_01-2011_en.pdf
Manufacturing Formula and Processing Instructions
Approved, written Manufacturing Formula and Processing Instructions should exist for each product and batch size to be manufactured.
4.17 The Manufacturing Formula should include:
a) The name of the product, with a product reference code relating to its specification;
b) A description of the pharmaceutical form, strength of the product and batch size;
c) A list of all starting materials to be used, with the amount of each, described; mention should be made of any substance that may disappear in the course of processing;
d) A statement of the expected final yield with the acceptable limits, and of relevant intermediate yields, where applicable