Stability Study in Pharmaceutical Industry

This training video will make you understand about importance of the stability studies, trend of FDA citations since last 4 years, expectations of ICH guide , FDA and other GMP guides from stability studies. Further this video will explain you all important stages to understand about stability studies in pharmaceutical industry.LEARNINGPHARMACY.IN
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[@ramakrishnaguttula7941]

Good Informative sir

[@hitendrakumarshah3718]

So nice of you

[@prasannakumar3242]

Thank you so much for providing pharmaceutical subjects God bless you plenty sir

[@hitendrakumarshah3718]

Thank you so much for your kind wishes.

[@sadiach2268]

How we conduct performance qualification of stability chamber

[@hitendrakumarshah3718]

The PQ involves temperature and RH variation/distribution study and also comparing with the controller which is near the door.

[@Littleadvik22]

If my product is not stable at 40°C/75%RH during long term testing in A Zone IV B, can I do long term testing at 25°C/75%RH. Any storage condition I need to mention at carton after getting the 25°C/75%RH data.

[@hitendrakumarshah3718]

40°C/75%RH is not a long-term condition. Can you please check again? This is an ACC condition. If ACC fails, you can test for intermediate conditions.

[@smarikapanwar9300]

Pls help me to clear,
For any ongoing product:
Do stability studies of three primary batches sufficient or Is it requires to do stability study of at least one batch every year?
In ICH Q1 R2 : Only three initial batches mentioned but just to verify,I want to know from you.

[@hitendrakumarshah3718]

If there is no chane in the product(packaging, forrmulation. process or any other change) - Only one product is enough for stability study at long term condition. The guideline is for "NEW DRUG SUBSTANCES AND PRODUCTS". For existing products - You need to follow SUPAC guide.

[@smarikapanwar9300]

@@hitendrakumarshah3718 Thank you Sir

[@hitendrakumarshah3718]

@@smarikapanwar9300 Welcome. Please keep learning !!!

[@shivsailamram4970]

Excellent and easily adoptable. Thanks

[@hitendrakumarshah3718]

Welcome. Keep Learning !!!

[@darshshukla156]

Nice informative video sir
I want to know that, if batch size change, api source change and equipment change, how many batches to b taken for stability studies

[@hitendrakumarshah3718]

You can club all changes and conduct complete stability study considering as a new product

[@bhausahebhingade3541]

Thanks you sir very knowledgeable information

[@hitendrakumarshah3718]

Welcome. Keep Learning !!!

[@saadmanzar876]

Great ... Respect from Pakistan

[@hitendrakumarshah3718]

Thank you. Please keep learning !!!

[@chiareddy7468]

Hi sir are vedios enough for training on csv or shall I join advance gmp

[@hitendrakumarshah3718]

Advance GMP membership allows to you discuss with me directly and clarify your doubts.

[@ThotaNarendraLifeSciences]

Very good videos sir..a big request, please do a video on formulations(what are the sops, docs, permission, regulatory works mandatory to required)and raw material to finished product process flow or steps for api, finished products🙏 thanks in advance sir

[@hitendrakumarshah3718]

Noted. I will take session on it

[@satya-qn2jd]

(1)For new drug product... Without completion of stability study. Can we launch in market.
(2). Without stability data how we can keep in market in routine drug product batch... Plz sir answer...

[@hitendrakumarshah3718]

Yes. you can launch the product without completion of stability study. On the basis of existing stability data, you can assign the shelf life.

[@janichem7864]

Sir any Webinar related to QC Compliance

[@hitendrakumarshah3718]

Sure, will organise the same

[@drjoyjit]

Such a great video!

[@hitendrakumarshah3718]

Thank you for your comment

[@dineshsonawane5464]

Great video Thank you

[@hitendrakumarshah3718]

Thank you. Please keep learning !!!

[@janichem7864]

Any Detail Webinar related to ISO 17025

[@hitendrakumarshah3718]

Sure. Will let you know

[@shrikantbhosale2167]

Very Nice...

[@hitendrakumarshah3718]

Thanks

[@sambhajibhanuse3]

Can you please elaborate Guideline Q1E...in simple terms.

[@hitendrakumarshah3718]

Sure. Will prepare on it. Thank you so much for your kind suggestion.

[@sambhajibhanuse3]

@@hitendrakumarshah3718 Thank you.. waiting....

[@vanajakshikota6885]

Hi sir, Kindly explain stability stress study to understand simply

[@hitendrakumarshah3718]

Sure. Thank you for your kind suggestion.

[@michaelkisselar5691]

Pecan anyone help me with the sample Stability Study Program format. I am in a new sterile parenteral Pharmaceutical and the first in my country. And I’m in a QC team. Among documents we should first prepare is Stability study Program, Environmental Monitoring Program. Please help

[@hitendrakumarshah3718]

Hi, Surely our organisation can help you to practially implement the stability study. Also, we can support for environement mornitoring program with risk based approach. I suggest, you can write detailed email [e-mail]
If you have technial queries, you can put in comment section only. Will revert to you. Thanks

[@vadlavallikanakarao3154]

Super

[@hitendrakumarshah3718]

Thanks

[@rajathathireddy3285]

Pls take next presentation on vendor management

[@hitendrakumarshah3718]

Sure. I will take separate online LIVE session.

[@swatilodhi7682]

Nice

[@hitendrakumarshah3718]

Thanks !!!

[@rajathathireddy3285]

Dear sir, I have doubt regarding stability Annual batch charging.
During any new product introduction we are taking validation batches as per FDA guidelines and if any changes we are doing in manufacturing or any equipment as per supac guidelines we are charging stability. Then what is the requirement of charging annual stability and as per FDA or WHO guidelines also not required to charge the annual stability. Why all pharma companies they are charging annual stability, what is the background pls explain sir.

[@hitendrakumarshah3718]

The annual stability charging is for the evaluation of long term storage if, there is not change(as per SUPAC). Because, always there is slight variability in product, process and other parameters. Hence the effect of such small variability can be studied. Hope, it clear your doubt.

[@hitendrakumarshah3718]

The annual stability charging is for the evaluation of long term storage if, there is not change(as per SUPAC). Because, always there is slight variability in product, process and other parameters. Hence the effect of such small variability can be studied. Hope, it clear your doubt.

[@prasannakumar3242]

God gives good health for you for ever

[@hitendrakumarshah3718]

Thank you so much for your kind wishes.

[@perumallachinna568]

Thanks you so much sir

[@hitendrakumarshah3718]

Welcome. Please keep learning !!!

[@bhausahebhingade3541]

Keep it up sir

[@hitendrakumarshah3718]

Thank you so much. If you have questions, you can post in comment section.

[@proogamerop5266]

Thank you sir

[@hitendrakumarshah3718]

YASH SHAH welcome Keep Learning

[@suribabu6316]

Hi sir
Thankyou for the sharingknowledge
Can you please help me to find
Most of the Drugsubstance have storage condition 15 to 30°....And stability study at temp 25 +/-2° ....How can we justify the stability above 27 and below 23°C....

[@hitendrakumarshah3718]

The recommended storage conditions are assigned based on Long term stability study. If there is excursion in storage need to be evaluated in detailed.

[@krishnadesai6953]

Hindi language psbl???

[@hitendrakumarshah3718]

Next time, I will post in English as well as in Hindi

[@vandyb9301]

Thanks Sir

[@hitendrakumarshah3718]

Welcome. Please keep learning !!!

[@sankarrao8288]

Explain briefly sir

[@hitendrakumarshah3718]

I tried to complete it in a short time. You can raise your questions. I will revert to you. Thanks

[@mansouralajeemi9101]

thank you Sir

[@hitendrakumarshah3718]

Thanks. Please keep learning !!!