3 stages and 4 types of Process Validation | FDA Guidance on process validation

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  • čas přidán 10. 09. 2024

Komentáře • 39

  • @PrasannaKumar-vm9rt
    @PrasannaKumar-vm9rt Před 4 lety +3

    Can you describe simply by denoting giidline name and number along with 21 cfr, anvisa , ich, other guidelines. Means
    Which guidelines refer to validation, qualification, investigation, risk assessment, change control, deviation, incidents, capa, root cause analysis, sampling techniques, manufacturing and packing, gdp, gmp. Etc
    Plz awaited for response.

  • @Smittaji
    @Smittaji Před rokem

    Audio is having too much base & subtitle is typing something which cannot be related to the conversation. good video, very hard to understand with the audio issues

  • @rajeshpaskanti8345
    @rajeshpaskanti8345 Před 8 dny

    Good👍

  • @IK-qu9hw
    @IK-qu9hw Před 5 lety +5

    Very nice.
    I am instrumentation engineer 2017 batch. After completion of degree I started working in automation field ( I have done oq ,pq of blender, RMG ,FBD machine also 21 cfr part 11 with end client. ) now I have 1 yr experience in automation field.since salary package is very less so now I am thinking to switch to pharma sector, I have one question what should I do now shall I switch to pharma or not?
    Plz reply..

  • @sailalith1989
    @sailalith1989 Před 5 lety +1

    Excellent it's helpful for me am IPQA Chemist.

  • @rutujapatankar19
    @rutujapatankar19 Před 4 lety +1

    Nicely explained. Thankyou

  • @pharma8975
    @pharma8975 Před 2 lety

    Nice explanation and superb

  • @amitkumarshukla3234
    @amitkumarshukla3234 Před 3 lety

    Very good explanation

  • @vaidikchetanmanch4858
    @vaidikchetanmanch4858 Před 3 lety

    Super se bhi upar

  • @Indianvlogs143A1
    @Indianvlogs143A1 Před 3 lety

    Tq excellent information

  • @vinayak8055
    @vinayak8055 Před 3 lety

    If long time years validation not done then there is need of revalidation ? Even there is no any change in process.OR It's available of any period of revalidation?

  • @boinikrishna3364
    @boinikrishna3364 Před 3 lety

    Sir in pharma IPQA vs AR&D which is best sir for better growth.. Please give me reply sir..

  • @badithalakishorekumar112

    Good information

  • @ramuboppani9254
    @ramuboppani9254 Před 2 lety

    Thanks for sharing

  • @pratikshawavale
    @pratikshawavale Před 4 lety

    Thanks for the guidance .keep making more videos for pharma learner like me.

  • @anilreddy1650
    @anilreddy1650 Před rokem

    Sir which guide line is supporting.

  • @krishnanvisva4137
    @krishnanvisva4137 Před rokem

    Super sir

  • @kartheekgoud5385
    @kartheekgoud5385 Před 4 lety +1

    Sir, why 3 batches are required for process validation??

    • @himanthmanne8447
      @himanthmanne8447 Před 3 lety

      look at the FDA regulations

    • @vishal11ism
      @vishal11ism Před 3 lety

      Two batches are not enough to provide statistic data, and 4 batches can be done but will be time consuming and pricey.

  • @niharranjanmeher4989
    @niharranjanmeher4989 Před 4 lety +3

    Sir..Plz remove the background music...

  • @girijarithi6806
    @girijarithi6806 Před 2 lety

    Super

  • @jigishapatel4487
    @jigishapatel4487 Před 3 lety

    Sir, can you please explain Process validation for EMA also ?? How does it differ there ??

  • @ParthPatel-wn6sp
    @ParthPatel-wn6sp Před rokem

    Please explain latest Process Validation theory.

  • @syedmuzamilshah8316
    @syedmuzamilshah8316 Před 4 lety

    superb

  • @govardhanreddy1891
    @govardhanreddy1891 Před 4 lety

    How many batches to take for re- validation

  • @ajayspecial3936
    @ajayspecial3936 Před 5 lety

    Superb

  • @PharmaPill
    @PharmaPill Před 6 lety +1

    👍🏻

  • @ravinpawar8638
    @ravinpawar8638 Před 5 lety

    Good ppt

  • @dhimanabhishek965
    @dhimanabhishek965 Před 4 lety +1

    Sir... Background music ko band kare

  • @munduruganesh3651
    @munduruganesh3651 Před 5 lety

    👌

  • @khushbookanojiya749
    @khushbookanojiya749 Před 4 lety

    Gud video but Plz Hindi m bhi discribe kare

  • @Rakeshkumar-xo2xv
    @Rakeshkumar-xo2xv Před 5 lety

    Plz speak in Hindi......

    • @pharmalearners3120
      @pharmalearners3120  Před 5 lety +1

      Thank you Rakesh for your suggestion, I will definitely implement it in future

  • @vijayaramakrishnapilli8583

    very nice explanation