Pharmaceutical interview questions on ICH stability guidelines|Part-1

What is Significant Change in Pharmaceutical Stability Testing?
Or
Can you explain what do you mean by significant changes?
This is the one of the frequently asked question in the interview.
In this tutorial you will learn how to define “Significant change” in a drug product or drug substances, according to ICH Q-1E guideline.

[@LTAS276L]

Nice

[@justmusicanddance1943]

Great explanation 👍👌💗

[@arunkumar-kw7by]

Nicely explained. Will you do videos on ich m7, Impurities guidelines and analytical method validations

[@abhaysingh5118]

Good explanation

[@PharmaPill]

👍🏻

[@janmejaygondhale6245]

thanks for this useful sharing..please provide more video on stability evaluation of the pharmaceutical dosage unit..

[@pharmalearners3120]

Thanks Janmejay for your feedback, give me some time we will also make tutorial on stability evaluation.

[@velkumaran7059]

A&C

[@PrakashSahu-fe6hq]

Pls give details about Drug substances and can assigned the Retest date based on development stability data

[@battinipoorna1909]

Mam what is limit of assay from previous interval ...and what is the limit for dissolution from initial valu

[@chanabasayyahiremath4470]

I need to know about rationale for selection specific concentration solution (e.g. 0.005M perchloric acid solution in UV calibration) during UV and HPLC calibration

[@pratikshawavale]

Option D.
Plese elaborate the analytical method validation regulatory review points

[@dedeepyagamingchanel2444]

Nice explaination

[@pharmalearners3120]

Thank you

[@mohanvashist986]

Madam plz clear about the significant change regarding vitamins in drug products

[@satyakoyyana5375]

In India zone IV A condition not initiated.. why? Please explain

[@legends-og5dx]

Explain mass spectroscopy

[@sureshmariappan3015]

Need ICH Q 6 explain

[@Mayank-pz4ew]

Tablets packing..question

[@tallapanenimahesh6334]

What is the difference in prospectic,concertic and retrosopic validation

[@pharmalearners3120]

Hi Mahesh, there are 4 types of validation prospective validation which is perform before production and during product development stage. Next is concurrent validation which is perform on the first three production scale batches. Third one is Retrospective validation which involves examination of past experiences and data, also called trend analysis. Fourth one is Revalidation, whenever any changes are made in existing system or process to evaluate and ensure there should not be adverse impact on product quality because of such change.
I will make one tutorial on this topic very shortly and explain it with more detailed examples. Keep watching and share this channel with your friends and colleagues. Thanks

[@Anita_0187]

@@pharmalearners3120 thank you

[@talatfakhri1909]

94

[@venkatnarayana6683]

A

[@PKvaghela0111]

C

[@prashantdarode40]

D

[@Mayank-pz4ew]

Plz send packing interview question...

[@pharmalearners3120]

Thanks, I will include it in my upcoming videos list

[@arunsalve3908]

94