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Prashant Sir official
เข้าร่วมเมื่อ 21 มิ.ย. 2012
FOR Pharma, Nutraceutical, Food and related PROFESSIONAL,
Assigning Expiry date, Shelf life, retest date
#assigningshelflife #expiry #retesting #ICH #Ichq1e #assigningexpiry
In this video, you will get the information on how to assign self-life, expiry date, or retest date to the finished product or to API. As per ICH Q1E guidelines if we have sufficient stability data based on that we can extrapolate the expiry date or re-test date beyond available stability study data based on 6 months of accelerated stability data and available long-term stability data. Explain with examples how to assign stability data in the case of general products that is products with recommended storage conditions below 25 degrees Celsius or 35 degrees Celsius 40 degrees Celsius and how to assign self-life or expiry date or retest date. Also explained how to assign self-life to Products having storage conditions under refrigeration. Extrapolation is not allowed for Frozen products. In case of frozen products self life shall be assigned based on available long-term or real-time stability.
In this video, you will get the information on how to assign self-life, expiry date, or retest date to the finished product or to API. As per ICH Q1E guidelines if we have sufficient stability data based on that we can extrapolate the expiry date or re-test date beyond available stability study data based on 6 months of accelerated stability data and available long-term stability data. Explain with examples how to assign stability data in the case of general products that is products with recommended storage conditions below 25 degrees Celsius or 35 degrees Celsius 40 degrees Celsius and how to assign self-life or expiry date or retest date. Also explained how to assign self-life to Products having storage conditions under refrigeration. Extrapolation is not allowed for Frozen products. In case of frozen products self life shall be assigned based on available long-term or real-time stability.
มุมมอง: 120
วีดีโอ
Difference between Shelf Life, Expiry date, Use before, Best before, use by date.
มุมมอง 21714 วันที่ผ่านมา
#shelflife #expirydate #Usebeforedate #Bestbeforedate #retest In this session, you will receive detailed information on the difference between "Best Before" and "Use Before, the terms "Expiry" and "Shelf Life", and the terms "Expiry date" and "retest date" "Best Before" and "Use Before" are terms used on food and product packaging to indicate different aspects of product safety and quality. The...
Cleaning validation PART 6 - Analytical method validation. AMV
มุมมอง 12728 วันที่ผ่านมา
#analyticalmethodofcleaningvalidation #cleaningvalidationmethodvalidation #AMV #cleaningvalidationAMV #swabsample #cleaningresidues #rinsemethodvalidaion #swabsampleresiduemethodvalidation Continuing the PART 1 to 5 videos, this video will provide you with further information on cleaning validation. This video will provide you with information on the Analytical method validation of cleaning res...
Cleaning validation :HOLD TIME STUDY ( Part 5)
มุมมอง 308หลายเดือนก่อน
#PPT #cleaning #cleaningvalidation #maco #macos #ssa #swabsample In continuation with PART 1, 2 , 3& 4 videos, this video will provide you with further information on Dirty and cleaned equipment hold time study procedure. Also providing link to download PPTs of all sessions. Refer to the link below to access previous parts. Part 4 :MACO calculations. th-cam.com/video/_-IM9khfPi4/w-d-xo.htmlsi=v...
Cleaning validation Part 4- MACO CALCULATIONS
มุมมอง 3722 หลายเดือนก่อน
#cleaning #cleaningvalidation #maco #macos #ssa #swabsample In continuation with PART 1, 2 & 3 videos, this video will provide you with further information on cleaning validation. This video will provide you with information on the Calculation of MACO based on PDE, ADE, of worst cases related to cleaning validation. It also provides a calculation of the Limit for Swab or Rinses samples, Limit f...
Worst cases in Cleaning validation #MACO #PDE #ADE #LD50 #MAC #MSR
มุมมอง 4282 หลายเดือนก่อน
#cleaning #cleaningvalidation In continuation with PART 1& 2 videos, this video will provide you with further information on cleaning validation. This video will provide you with information on the selection of worst cases related to cleaning validation. i.e. Worst-case product, worst-case sampling location, how to select worst case, criteria like solubility, potency, toxicity, LD50, PDE, ADE e...
CLEANING VALIDATION- PART 2 : PROTOCOL & REPORT
มุมมอง 5172 หลายเดือนก่อน
In continuation with PART 1 in this video, I have explained in detail the documentation requirements for cleaning validation and how to write in cleaning validation protocol and report. Elaborated on contents, annexures, and other areas that need to be considered while drafting protocol and reports for cleaning validation, for example, objective, scope, procedure, method validation, sampling me...
CLEANING VALIDATION PART 1: BASIC UNDERSTANDING
มุมมอง 9003 หลายเดือนก่อน
Dear friends, we are going to discuss cleaning validation. This activity is distributed in 7 different sessions. In today's session, we discussed the basic concept of cleaning validation, the meaning of cleaning validation, and different types of cleaning validation. Why cleaning validation is important. Stages of cleaning validation. Which those areas need to be considered for cleaning validat...
Water for Pharmaceutical Use
มุมมอง 5753 หลายเดือนก่อน
In this video, we discussed the importance of water and the different types of Water used in the pharmaceutical industry. We also discussed the Revised Schedule M expectation concerning the water to be used in Formulation, API, liquid orals, sterile preparations & three phases of water system validation, Generation of purified water, water for injection, etc. Hashtags #prashantsirofficial #wate...
Contamination control: STRATEGIES, SOURCES AND CONTROL
มุมมอง 1774 หลายเดือนก่อน
Contamination control: This video will provide you details about the approach to the contamination, Contamination control, different source of contamination, definition of contamination, different types of contamination. physical chemical microbiological Mix ups Cross contamination, allergens & it's different types. Also referred to different sources of contamination. I have also explain about ...
Differential pressure and Negative/ positive pressure in different cubicles of classified areas.
มุมมอง 1.9K4 หลายเดือนก่อน
This video will provide you information on importance of differential pressure in clean room areas, Pharma API Food industry. Regulatory requirement about differential pressure. How to set the limit for differential pressure between two cubical in same class or same grade and differential pressure in adjacent room having two different grade or two different classes. This video will also provide...
HACCP TACCP VACCP- RISK ASSESSMENT.
มุมมอง 2204 หลายเดือนก่อน
This video will provide you information about Definition of HACCP, VACCP, TACCP, DIFFRENCE BETWEEN HACCP, VACCP, TACCP. Applicability and benefits of using these three risk assessment tools. Why we need TACCP & VACCP although we have HACCP. What are different threats to our business. What are different types of food frauds. #qrm #riskmanagement #haccp #VACCP #TACCP #riskassessment
AREA CLASSIFICATION, Clean room classification.
มุมมอง 4.7K5 หลายเดือนก่อน
CLASSIFICATION OF CLEAN ROOMS as per , ISO 14644-1, Federal Standards (FS 209), European standards WHO TRS SCHEDULE M ISO 5 ISO 6 ISO 7 ISO 8 Class100 Class1000 Class 10,000 Class100,000 Grade A Grade B Grade C Grade D #areaclassification #iso #who #FS209#cleanroomclassification #hvac
CLEAN ROOM GARMENTS - GMP APPEARALS / GARMENTS
มุมมอง 1796 หลายเดือนก่อน
This video provides information on clean room gowning, selection of appropriate cleanroom garments, crucial elements / key consideration for selection of GMP apparels/ clean room linen. Also provide information on relation between correct garment and area class, gowning and activities, different aspects of garments, GMP/ QMS requirement for correct gowning etc. #GarmentsinFoodIndustry #Garments...
DATA INTEGRITY BREACHES : REASON & REMEDIES
มุมมอง 2266 หลายเดือนก่อน
This video provides information "HOW TO AVOID DATA INTEGRITY RELATED ISSUES" It will be helpful to avoid 483, import alert, critical observations in regulatory Audits. Explain the why and how Data integrity beaches what are the way forward to overcome the Data integrity related issues. Also Link provided for detailed information on Data Integrity & ALCOA Principles, acronym 'ALCOA', Attributabl...
MICROBIOLOGICAL ANALYSIS IN PHARMA INDUSTRY.
มุมมอง 2077 หลายเดือนก่อน
MICROBIOLOGICAL ANALYSIS IN PHARMA INDUSTRY.
Do's and Don'ts of HPL Chromatography.
มุมมอง 2337 หลายเดือนก่อน
Do's and Don'ts of HPL Chromatography.
REVISED SCHEDULE M | Content and Changes | PART 4 |
มุมมอง 5318 หลายเดือนก่อน
REVISED SCHEDULE M | Content and Changes | PART 4 |
FISHBONE DIAGRAM | CAUSE AND EFFECT DIAGRAM | ISHIKAWA DIAGRAM
มุมมอง 2098 หลายเดือนก่อน
FISHBONE DIAGRAM | CAUSE AND EFFECT DIAGRAM | ISHIKAWA DIAGRAM
Good Laboratory Practices ( GLP ) | SESSION 2| SCHEDULE L1|
มุมมอง 2219 หลายเดือนก่อน
Good Laboratory Practices ( GLP ) | SESSION 2| SCHEDULE L1|
Good Laboratory Practices ( GLP ) | SESSION 1| SCHEDULE L1|
มุมมอง 41610 หลายเดือนก่อน
Good Laboratory Practices ( GLP ) | SESSION 1| SCHEDULE L1|
Revised Schedule M: Content and Changes | PART 3 |
มุมมอง 87410 หลายเดือนก่อน
Revised Schedule M: Content and Changes | PART 3 |
Revised Schedule M: Content and Changes | PART 2 |
มุมมอง 81311 หลายเดือนก่อน
Revised Schedule M: Content and Changes | PART 2 |
Revised Schedule M: Content and Changes.
มุมมอง 1.3K11 หลายเดือนก่อน
Revised Schedule M: Content and Changes.
Data Integrity & ALCOA Principles | ALCOA+ | ALCOA++
มุมมอง 76811 หลายเดือนก่อน
Data Integrity & ALCOA Principles | ALCOA | ALCOA
Career Opportunities in "Pharma Industry".
มุมมอง 26511 หลายเดือนก่อน
Career Opportunities in "Pharma Industry".
I was waiting for this video. Thank you.
Is this extrapolation acceptable to authority, mainly regulated market.
Yes it is acceptable
Sir its raghu thanks. Can u pl. Tell how to assign the expiry to the api as some vendor di not give expiry of there products. Ex. Sls
If they don't assign expiry that means you need to retest retest it periodically. May be once in year and continue max up to 5 yrs. You can also ask vendor to provide stability data and based on that you can assign expiry as explained in this video
HBEL-based MACO is a new concept for me. Thank you for sharing.
Basic but very important information. Waiting for SESSION ON HOW TO ASSIGN SHELF LIFE
Sir ours is new facility when should we do the cleaning validation as we dont have any products What is actual process
Initially you can start with sampling and testing Swab and Rinse for each equipment after every product changeover. Once you have sufficient products then you can go for cleaning validation. May be after 5 - 10 products
Greatly explained
Thank you
Very informative 👍
please do one video on AMV also.
Very good topic sir
Your Simple and clear explanation made us understand and clear our confusions. Thank you
You are really good teacher
This is very intresting topic and useful for every one
Thank you for sharing
Well explained sir. Very useful for QC and QA
You are work for humanity through help to person who does not have other source to aware about the cGMP. Really appreciate.
Thank you so much
Very nice sir
Hello sir environmental monitoring pe video bnaye full guideline ke sath pls air
Ok Sure
Very lucid explanation so that even laymen can understand
Informative session, Keep it up
Thank you so much
Got the excel sheet, could download. Thank you Sir, Venugopal
Differential pressure:- Cascade,Sink & Bubble Airlock , Setting DP limit gets value addition in GK.❤
Thanks
Sir, can you please give a session on shelf life studies requirements as per USFDA and revised Schedule M? Thank you very much 🙏 Venugopal
Yes we will cover it under Stability studies. Meanwhile you can refer to ICH Q1E
Area Classification covered very preciously ❤
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For Market Complaint - great tool to identify Root caused via Fishbone/Ishikawa/Cause & Effect Diagram - This video was provide holistic approach finding Root caused Analysis. ❤
Very nice sir
Sir kripya Hindi me bhi samjane ki kripa kren
ओके कोशिश karunga हिंदी aaur English both
Please share pdf copy of all parts of Cleaning validation Sir
Noted. Will send link in upcoming videos
Guidance value from which guideline u have taken sir.
WHO TRS 1019
Annex 2
please prepare separate video on sterility and validation
Will do on sterility, media fill
Sir please explain in english So that it can be understood to all viewers
Ok Noted
Sir area qualification kaise karet hai
Will do one video on Area Qualification in aug.
Sir cleaning validation pe video banaiye
Yes 3 videos already posted
th-cam.com/video/6yHpM6ZzhHQ/w-d-xo.htmlsi=jIVsZoPfIJdpL4yO
th-cam.com/video/BEavWYn3JuM/w-d-xo.htmlsi=F758qr95R68Iyjsu
th-cam.com/video/tHZP9JhZFWA/w-d-xo.htmlsi=qe-4yav91A7GG4p2
Refer above link for cleaning validation
Area qualification kitna din me clear hota hai
Thanks for sharing. Very well explained. Sir also explain temperature mapping in pharmaceutical industries in OSD
Will target in last week of Aug
Sir please also make a detail video on temperature mapping
Hi sir Can solubility is selected only for API or all ingredients which are available in that product.
Only for APIs
Sir please share pdf copy the slides of all parts of Cleaning validation
Very nice
Thanks
Very Informative video must be watched before any interview
Pls use English while speaking sir
Please learn hindi
Thank you for sharing Sir
Must watch everybody. Well explained.
Sir, Graphics need to be included in the Report also if it is there in the Protocol. I believe it is ok only with protocol.
Good explained sir ji 🙏 very easy learning any one a critical topic explanation by you
Thanks a lot
Cleaning Validation step by Step ❤
The first time I understood the area classification correctly. Very well explained sir.
If hot water is to be used for cleaning validation @ what temperature.
Water temperature shall be decided on the nature of your product, which must be defined in the SOP. Usually, it ranges between 40 deg. c to 75 deg C. If your bio-load is high then better to go for 75 deg C. Else lower temp. is ok.
Sir cleaning disinfectant change hua hai ky teepol ka remove kiy gya gai
It is recommended to avoid. Best option is hot water.
If need to use cleaning agent then need to save safety data. You can ask your supplier to provide data or based on composition you need check for MSDS