i have a question: how many samples do we need to take finised product in pharmaceutical company? For example, for 3 times of analysis finished product we need about 100 tablets, packging type is 10 tablets each blister, a box 3 blisters. So how many boxes do we need to take? is there any guidance in GMP WHO or EU for that? Pls reply, thank you so much
Validation of method....very important concept
Great presentation, very useful. Can I ask whether the table you put up for when to validate for drug substance applies to drug product too?
When in the video was that table put up? I will check with our analytical team.
Hi, is forced deg performed on impurity method validation?
Not all validations include forced degradation. If you ask for a stability indicating method, forced degradation will be included.
i have a question: how many samples do we need to take finised product in pharmaceutical company? For example, for 3 times of analysis finished product we need about 100 tablets, packging type is 10 tablets each blister, a box 3 blisters. So how many boxes do we need to take? is there any guidance in GMP WHO or EU for that? Pls reply, thank you so much
Can you rephrase your question please
Good one
For calculating Detection limits as per ICH Q2 by Linear regression and MS Excel. Refer the video
th-cam.com/video/Ii2Z3hqwRGM/w-d-xo.html