Prashant Sir official
Prashant Sir official
  • Видео 39
  • Просмотров 26 370
RECAP OF ALL VIDEOS ON VALIDATION QUALIFICATION UTILITY GMP GLP
#prashantsirofficial
#Pharmafoodnutra
#validation #gmp #areaclassification
The links are provided for all 38 videos uploaded to this channel.
Resume writing, Curriculum writing, Interviews call, Interviews.
ruclips.net/video/bL8X6bJMMOQ/видео.htmlsi=oDxv_qKeZuP3jo8U
Interview preparation | Facing an interview
ruclips.net/video/kQuJMjyAu34/видео.htmlsi=NxzSqdVNjsojbsFq
Common Interview Questions and Answers
ruclips.net/video/i1SytllzHZY/видео.htmlsi=sM8zd1QItfc6Yown
Demo on Common Interview Questions
ruclips.net/video/1FG23XgaKl4/видео.htmlsi=9M5mlVw40fMwy9Gq
Information about salary structure, CTC, Gross Salary, Net Salary
ruclips.net/video/27uPv7qgD9E/видео.htmlsi=JJKZiLQLVc2q3sUD
Success Motivation
ru...
Просмотров: 128

Видео

MEDIA FILLS - ASEPTIC PROCESS SIMULATION STUDY
Просмотров 18521 день назад
This video will provide information on media fill study or aseptic process simulation study. This video will provide information about media fill study design, required routine interventions, non routine interventions to be considered during media fill study. Details about incubation requirements , Pre- incubation inspection, post incubation inspection, frequency of media fill studies, frequenc...
Temperature Mapping or Temperature Profiling in Pharma.
Просмотров 295Месяц назад
#Temperaturemapping #Temperatureprofiling #temperature #temperaturemonitoring #hotspot #hotspots #coldspots In this video, I have explained about Stages of the temperature-mapping process considering Regulatory References. You will get answers to all the below questions related to temperature mapping or temperature profiling. • Why is Temperature Mapping Critical? • How to perform Risk Assessme...
QR Code, Data Matrix code, Bar code: Differences and usage
Просмотров 185Месяц назад
#qrcodes #qrcodevideos #qr #datamatrix #2dcode #1dcode #qrcodelabels #datamatrixlabels #barcodelabels In this video, you will learn about Barcodes, QR codes, data Matrix codes, UPC codes, ENA codes. What is the difference between all these codes? what is the data storage capacity of these codes? where it is applicable? How do they work? everything is discussed in this video. what is the applica...
Assigning Expiry date, Shelf life, retest date
Просмотров 207Месяц назад
#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 accele...
Difference between Shelf Life, Expiry date, Use before, Best before, use by date.
Просмотров 3202 месяца назад
#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
Просмотров 2022 месяца назад
#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)
Просмотров 4153 месяца назад
#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. ruclips.net/video/_-IM9khfPi4/видео.htmlsi=v...
Cleaning validation Part 4- MACO CALCULATIONS
Просмотров 5783 месяца назад
#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
Просмотров 6834 месяца назад
#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
Просмотров 7474 месяца назад
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
Просмотров 1,3 тыс.4 месяца назад
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
Просмотров 6735 месяцев назад
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
Просмотров 2155 месяцев назад
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.
Просмотров 3 тыс.6 месяцев назад
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.
Просмотров 2986 месяцев назад
HACCP TACCP VACCP- RISK ASSESSMENT.
AREA CLASSIFICATION, Clean room classification.
Просмотров 7 тыс.7 месяцев назад
AREA CLASSIFICATION, Clean room classification.
CLEAN ROOM GARMENTS - GMP APPEARALS / GARMENTS
Просмотров 1918 месяцев назад
CLEAN ROOM GARMENTS - GMP APPEARALS / GARMENTS
DATA INTEGRITY BREACHES : REASON & REMEDIES
Просмотров 2538 месяцев назад
DATA INTEGRITY BREACHES : REASON & REMEDIES
Quality Risk Management
Просмотров 3338 месяцев назад
Quality Risk Management
MICROBIOLOGICAL ANALYSIS IN PHARMA INDUSTRY.
Просмотров 2179 месяцев назад
MICROBIOLOGICAL ANALYSIS IN PHARMA INDUSTRY.
Do's and Don'ts of HPL Chromatography.
Просмотров 2369 месяцев назад
Do's and Don'ts of HPL Chromatography.
REVISED SCHEDULE M | Content and Changes | PART 4 |
Просмотров 5659 месяцев назад
REVISED SCHEDULE M | Content and Changes | PART 4 |
FISHBONE DIAGRAM | CAUSE AND EFFECT DIAGRAM | ISHIKAWA DIAGRAM
Просмотров 23210 месяцев назад
FISHBONE DIAGRAM | CAUSE AND EFFECT DIAGRAM | ISHIKAWA DIAGRAM
TIME MANAGEMENT | समय प्रबंधन |
Просмотров 19710 месяцев назад
TIME MANAGEMENT | समय प्रबंधन |
FACING AN AUDIT
Просмотров 21711 месяцев назад
FACING AN AUDIT
Good Laboratory Practices ( GLP ) | SESSION 2| SCHEDULE L1|
Просмотров 23211 месяцев назад
Good Laboratory Practices ( GLP ) | SESSION 2| SCHEDULE L1|
Good Laboratory Practices ( GLP ) | SESSION 1| SCHEDULE L1|
Просмотров 44711 месяцев назад
Good Laboratory Practices ( GLP ) | SESSION 1| SCHEDULE L1|
Revised Schedule M: Content and Changes | PART 3 |
Просмотров 906Год назад
Revised Schedule M: Content and Changes | PART 3 |
Revised Schedule M: Content and Changes | PART 2 |
Просмотров 866Год назад
Revised Schedule M: Content and Changes | PART 2 |

Комментарии

  • @NagarajMarkal
    @NagarajMarkal День назад

    Good information sir🙏

  • @official_sanjeev8765
    @official_sanjeev8765 4 дня назад

    Hello sir , ACPH limit , any reference for guidelines

  • @mayurkale5357
    @mayurkale5357 4 дня назад

    Sir- Please make a video on process validation.

  • @mayurkale5357
    @mayurkale5357 5 дней назад

    Thanks for Drive Sheet. It will be helpful to us.

  • @mayurkale5357
    @mayurkale5357 6 дней назад

    Very 👍

  • @mayurkale5357
    @mayurkale5357 6 дней назад

    Why related substance test is required in cleaned equipment at 0 hour?

    • @PrashantPatil-xc5et
      @PrashantPatil-xc5et 6 дней назад

      to ensure that the equipment is clean and free of contamination before the study begins. And understand trend if it was not free from RS.

  • @mayurkale5357
    @mayurkale5357 6 дней назад

    It is better to us if you provide the guideline reference with topics.

    • @PrashantPatil-xc5et
      @PrashantPatil-xc5et 4 дня назад

      20 November 2014 EMA/CHMP/ CVMP/ SWP/169430/2012 Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

    • @PrashantPatil-xc5et
      @PrashantPatil-xc5et 4 дня назад

      WHO TRS 1033 Annex 2

  • @mayurkale5357
    @mayurkale5357 6 дней назад

    After multiplying 1000 two times in formula I get MACO 104,166.66666666. How, you convert it in 104.17 mg?

    • @PrashantPatil-xc5et
      @PrashantPatil-xc5et 3 дня назад

      Ohh you are right it's typo error from my side. Thank you for correcting and sorry for inconvenience.

  • @mayurkale5357
    @mayurkale5357 6 дней назад

    Is it mandatory to consider a safety factor in new approach?

    • @PrashantPatil-xc5et
      @PrashantPatil-xc5et 6 дней назад

      @@mayurkale5357 No. In new approach safety factor is removed from MACO calculation.

  • @sandipmali1273
    @sandipmali1273 9 дней назад

    Very nice to recap and current expection.

  • @GauravRaghuvanshi-u9y
    @GauravRaghuvanshi-u9y 13 дней назад

    Sir please make video on bubble point test integrity

  • @AshaDorage
    @AshaDorage 19 дней назад

    Sir, why only SCDM is use for media fill study.

    • @PrashantPatil-xc5et
      @PrashantPatil-xc5et 19 дней назад

      @@AshaDorage it's general purpose media which supports growth of all type of Microbes

  • @amardhane2222
    @amardhane2222 20 дней назад

    clear and concise summary ❤

  • @amardhane2222
    @amardhane2222 20 дней назад

    Pudhari Look ❤ Sir ,Maharashtra Election nomination to be filing ?

  • @SonamSusvirkar
    @SonamSusvirkar 21 день назад

    Good informative

  • @Thangapandi-zy1ol
    @Thangapandi-zy1ol 24 дня назад

    DP accuracy value (+ or - ) 5 mmwc is acceptable or not acceptable sir

  • @hemantshetty3759
    @hemantshetty3759 Месяц назад

    Congratulations on 100 subscriptions

  • @tejshrisarawade7045
    @tejshrisarawade7045 Месяц назад

    simply great sir

  • @SonamSusvirkar
    @SonamSusvirkar Месяц назад

    Ohh its interesting very nice information

  • @Chikuonline
    @Chikuonline Месяц назад

    Thank you sir for sharing such a good content

  • @bhvaneshwarkumarpandey2866
    @bhvaneshwarkumarpandey2866 Месяц назад

    Sir Data integrity and Gdp per banayeye

  • @ghousemohd8955
    @ghousemohd8955 Месяц назад

    Nice video and good information sir..need continue videos regarding new lab setup like equipment qualification documents etc..mainly about microbiology

  • @pankajbisht9028
    @pankajbisht9028 Месяц назад

    Nice sir please make video regarding equipment qualifications.

  • @shashankdwivedi8470
    @shashankdwivedi8470 Месяц назад

    Please inform BMR process.

    • @PrashantPatil-xc5et
      @PrashantPatil-xc5et Месяц назад

      Will do one video on Batch record presentation and review

  • @Bharathraju-DBRx
    @Bharathraju-DBRx Месяц назад

    Good Explanation but drive link is not working.

  • @patilnandkishor48
    @patilnandkishor48 Месяц назад

    Thanks Sir, Content is very informative and useful 🙏

  • @RaviGupta-tl3hr
    @RaviGupta-tl3hr Месяц назад

    Wow ! Sir Thanks for giving most informative knowledge for people who are working in pharmaceutical industries. I admire you 🙏

  • @01santy
    @01santy Месяц назад

    Nice initiative

  • @tejshrisarawade7045
    @tejshrisarawade7045 Месяц назад

    interesting

  • @hemantkale2743
    @hemantkale2743 Месяц назад

    Nice information sir

  • @hemantkale2743
    @hemantkale2743 Месяц назад

    Very useful and knowledgeable information sir👍

  • @tejshrisarawade7045
    @tejshrisarawade7045 Месяц назад

    I was waiting for this video. Thank you.

  • @SonamSusvirkar
    @SonamSusvirkar Месяц назад

    Is this extrapolation acceptable to authority, mainly regulated market.

  • @raghu.kurudikurudi2889
    @raghu.kurudikurudi2889 Месяц назад

    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

    • @PrashantPatil-xc5et
      @PrashantPatil-xc5et Месяц назад

      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

  • @tejshrisarawade7045
    @tejshrisarawade7045 2 месяца назад

    HBEL-based MACO is a new concept for me. Thank you for sharing.

  • @tejshrisarawade7045
    @tejshrisarawade7045 2 месяца назад

    Basic but very important information. Waiting for SESSION ON HOW TO ASSIGN SHELF LIFE

  • @abuuhhemedy2077
    @abuuhhemedy2077 2 месяца назад

    Sir ours is new facility when should we do the cleaning validation as we dont have any products What is actual process

    • @PrashantPatil-xc5et
      @PrashantPatil-xc5et 2 месяца назад

      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

  • @vishalbhosale555
    @vishalbhosale555 2 месяца назад

    Greatly explained

  • @ambarjain08
    @ambarjain08 2 месяца назад

    Very informative 👍

  • @tejshrisarawade7045
    @tejshrisarawade7045 2 месяца назад

    please do one video on AMV also.

  • @SanjaykumarYashpalSinghVerma
    @SanjaykumarYashpalSinghVerma 2 месяца назад

    Very good topic sir

  • @SonamSusvirkar
    @SonamSusvirkar 2 месяца назад

    Your Simple and clear explanation made us understand and clear our confusions. Thank you

  • @SonamSusvirkar
    @SonamSusvirkar 2 месяца назад

    You are really good teacher

  • @SonamSusvirkar
    @SonamSusvirkar 2 месяца назад

    This is very intresting topic and useful for every one

  • @minalpatil4563
    @minalpatil4563 2 месяца назад

    Thank you for sharing

  • @minalpatil4563
    @minalpatil4563 2 месяца назад

    Well explained sir. Very useful for QC and QA

  • @pankajbisht9028
    @pankajbisht9028 2 месяца назад

    You are work for humanity through help to person who does not have other source to aware about the cGMP. Really appreciate.

  • @pankajbisht9028
    @pankajbisht9028 2 месяца назад

    Very nice sir

  • @vishalchaudhary3266
    @vishalchaudhary3266 2 месяца назад

    Hello sir environmental monitoring pe video bnaye full guideline ke sath pls air

  • @isovenu
    @isovenu 2 месяца назад

    Very lucid explanation so that even laymen can understand