临床样品留样期限

麦香晓慧

有没有老师可以解读一下，
1.临床试验用药品，是指成品，还是包括制备过程中的原液、半成品等？
2.原液、半成品这些中间产品也需要跟成品一样的留样这么久吗？

near

首先，你的半成品定义是什么，灭菌半成品还是待包装半成品还是其他。。。临床使用的肯定是合格的产品，外包装不一定要有。。。原液怎么留样？过不了几天就变质了吧，留了有什么意义，半成品看是从哪个工序出来的

麦香晓慧

near 发表于 2022-4-14 16:36
首先，你的半成品定义是什么，灭菌半成品还是待包装半成品还是其他。。。临床使用的肯定是合格的产品，外包 ...

半成品分装后冻干就是成品，半成品是液体的无菌包装，这样留样期限是跟成品一样？还是只需要留样至成品检验合格之日？

Sandy12345

WHO生物制品GMP中的这句话希望能帮到你，
WHO good manufacturing practices for biological products：
Reference samples of biological starting materials should be
retained under the recommended storage conditions for at least 1 year
beyond the expiry date of the corresponding finished product. Reference
samples of other starting materials (other than solvents, gases and
water) as well as intermediates for which critical parameters cannot be
tested in the final product should be retained for at least 2 years after
the release of the product if their stability allows for this storage period.
Certain starting materials such as components of growth media need not
necessarily be retained.