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Stability Study in Pharmaceutical Industry 

Hitendrakumar Shah
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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
Cadila, Sanofi,Zydus, AstraZeneca,Mylan,Interview Questions with Sharma Ji,ASK Mechnology,emainfo,Qualistery - GMP Content,easy medical device

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13 июл 2020

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Комментарии : 72   
@prasannakumar3242
@prasannakumar3242 4 года назад
Thank you so much for providing pharmaceutical subjects God bless you plenty sir
@hitendrakumarshah3718
@hitendrakumarshah3718 4 года назад
Thank you so much for your kind wishes.
@shivsailamram4970
@shivsailamram4970 4 года назад
Excellent and easily adoptable. Thanks
@hitendrakumarshah3718
@hitendrakumarshah3718 4 года назад
Welcome. Keep Learning !!!
@bhausahebhingade3541
@bhausahebhingade3541 3 года назад
Thanks you sir very knowledgeable information
@hitendrakumarshah3718
@hitendrakumarshah3718 3 года назад
Welcome. Keep Learning !!!
@drjoyjit
@drjoyjit 3 года назад
Such a great video!
@hitendrakumarshah3718
@hitendrakumarshah3718 3 года назад
Thank you for your comment
@saadmanzar876
@saadmanzar876 2 года назад
Great ... Respect from Pakistan
@hitendrakumarshah3718
@hitendrakumarshah3718 2 года назад
Thank you. Please keep learning !!!
@dineshsonawane5464
@dineshsonawane5464 3 года назад
Great video Thank you
@hitendrakumarshah3718
@hitendrakumarshah3718 3 года назад
Thank you. Please keep learning !!!
@mansouralajeemi9101
@mansouralajeemi9101 Год назад
thank you Sir
@hitendrakumarshah3718
@hitendrakumarshah3718 10 месяцев назад
Thanks. Please keep learning !!!
@perumallachinna568
@perumallachinna568 4 года назад
Thanks you so much sir
@hitendrakumarshah3718
@hitendrakumarshah3718 4 года назад
Welcome. Please keep learning !!!
@ThotaNarendraLifeSciences
@ThotaNarendraLifeSciences 11 месяцев назад
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
@hitendrakumarshah3718 10 месяцев назад
Noted. I will take session on it
@vadlavallikanakarao3154
@vadlavallikanakarao3154 Год назад
Super
@hitendrakumarshah3718
@hitendrakumarshah3718 Год назад
Thanks
@vandyb9301
@vandyb9301 4 года назад
Thanks Sir
@hitendrakumarshah3718
@hitendrakumarshah3718 4 года назад
Welcome. Please keep learning !!!
@darshshukla156
@darshshukla156 3 года назад
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
@hitendrakumarshah3718 3 года назад
You can club all changes and conduct complete stability study considering as a new product
@shrikantbhosale2167
@shrikantbhosale2167 Год назад
Very Nice...
@hitendrakumarshah3718
@hitendrakumarshah3718 Год назад
Thanks
@prasannakumar3242
@prasannakumar3242 4 года назад
God gives good health for you for ever
@hitendrakumarshah3718
@hitendrakumarshah3718 4 года назад
Thank you so much for your kind wishes.
@bhausahebhingade3541
@bhausahebhingade3541 3 года назад
Keep it up sir
@hitendrakumarshah3718
@hitendrakumarshah3718 3 года назад
Thank you so much. If you have questions, you can post in comment section.
@Littleadvik22
@Littleadvik22 2 года назад
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
@hitendrakumarshah3718 2 года назад
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.
@vanajakshikota6885
@vanajakshikota6885 3 года назад
Hi sir, Kindly explain stability stress study to understand simply
@hitendrakumarshah3718
@hitendrakumarshah3718 3 года назад
Sure. Thank you for your kind suggestion.
@satya-qn2jd
@satya-qn2jd 3 года назад
(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
@hitendrakumarshah3718 3 года назад
Yes. you can launch the product without completion of stability study. On the basis of existing stability data, you can assign the shelf life.
@rajathathireddy3285
@rajathathireddy3285 4 года назад
Pls take next presentation on vendor management
@hitendrakumarshah3718
@hitendrakumarshah3718 4 года назад
Sure. I will take separate online LIVE session.
@sadiach2268
@sadiach2268 7 месяцев назад
How we conduct performance qualification of stability chamber
@hitendrakumarshah3718
@hitendrakumarshah3718 6 месяцев назад
The PQ involves temperature and RH variation/distribution study and also comparing with the controller which is near the door.
@swatilodhi7682
@swatilodhi7682 3 года назад
Nice
@hitendrakumarshah3718
@hitendrakumarshah3718 3 года назад
Thanks !!!
@janichem7864
@janichem7864 Месяц назад
Sir any Webinar related to QC Compliance
@hitendrakumarshah3718
@hitendrakumarshah3718 21 день назад
Sure, will organise the same
@sambhajibhanuse3
@sambhajibhanuse3 3 года назад
Can you please elaborate Guideline Q1E...in simple terms.
@hitendrakumarshah3718
@hitendrakumarshah3718 3 года назад
Sure. Will prepare on it. Thank you so much for your kind suggestion.
@sambhajibhanuse3
@sambhajibhanuse3 3 года назад
@@hitendrakumarshah3718 Thank you.. waiting....
@chiareddy7468
@chiareddy7468 9 месяцев назад
Hi sir are vedios enough for training on csv or shall I join advance gmp
@hitendrakumarshah3718
@hitendrakumarshah3718 9 месяцев назад
Advance GMP membership allows to you discuss with me directly and clarify your doubts.
@michaelkisselar5691
@michaelkisselar5691 3 года назад
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
@hitendrakumarshah3718 3 года назад
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 nadhgmp@gmail.com If you have technial queries, you can put in comment section only. Will revert to you. Thanks
@janichem7864
@janichem7864 Месяц назад
Any Detail Webinar related to ISO 17025
@hitendrakumarshah3718
@hitendrakumarshah3718 21 день назад
Sure. Will let you know
@smarikapanwar9300
@smarikapanwar9300 Год назад
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
@hitendrakumarshah3718 Год назад
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
@smarikapanwar9300 Год назад
@@hitendrakumarshah3718 Thank you Sir
@hitendrakumarshah3718
@hitendrakumarshah3718 Год назад
@@smarikapanwar9300 Welcome. Please keep learning !!!
@suribabu6316
@suribabu6316 4 года назад
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
@hitendrakumarshah3718 4 года назад
The recommended storage conditions are assigned based on Long term stability study. If there is excursion in storage need to be evaluated in detailed.
@sankarrao8288
@sankarrao8288 2 года назад
Explain briefly sir
@hitendrakumarshah3718
@hitendrakumarshah3718 2 года назад
I tried to complete it in a short time. You can raise your questions. I will revert to you. Thanks
@rajathathireddy3285
@rajathathireddy3285 3 года назад
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
@hitendrakumarshah3718 3 года назад
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
@hitendrakumarshah3718 3 года назад
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.
@krishnadesai6953
@krishnadesai6953 2 года назад
Hindi language psbl???
@hitendrakumarshah3718
@hitendrakumarshah3718 2 года назад
Next time, I will post in English as well as in Hindi
@ajjjjugaming
@ajjjjugaming 3 года назад
Hindi me batayenge to jada subs badhenge
@hitendrakumarshah3718
@hitendrakumarshah3718 3 года назад
I agree. But all documents will be followed in India is in English. Thank you so much for your kind suggestion.
@proogamerop5266
@proogamerop5266 4 года назад
Thank you sir
@hitendrakumarshah3718
@hitendrakumarshah3718 4 года назад
YASH SHAH welcome Keep Learning
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