Analytical Method Validation and Transfer (4 of 6)

This a video of a seminar titled, Analytical Method Strategies for Drug Development, presented in November 2013 at Regis Technologies inc., Morton Grove, IL www.registech.com/analytical-...

[@kalpesh125]

Good one

[@jankithakker6232]

Validation of method....very important concept

[@sarahsmyth585]

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?

[@Registech]

When in the video was that table put up? I will check with our analytical team.

[@ngocnguyen-fx4zb]

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

[@ithirstyforknowledge]

Can you rephrase your question please

[@ithirstyforknowledge]

Hi, is forced deg performed on impurity method validation?

[@Registech]

Not all validations include forced degradation. If you ask for a stability indicating method, forced degradation will be included.

[@Infiniteanalyst]

For calculating Detection limits as per ICH Q2 by Linear regression and MS Excel. Refer the video
czcams.com/video/Ii2Z3hqwRGM/video.html