Process Validation in Pharma, FDA Guidance?

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  • เผยแพร่เมื่อ 21 ก.ย. 2024
  • Process Validation in Pharma, What is FDA Guidance? #usfda #pharma #validation #process @PHARMAVEN
    Types and stages of Process Validation and US
    FDA Guidance on process validation.
    In this tutorial i will correlate the types of
    process validation with these three stages of
    validation suggested by the US FDA.
    There are three are stages of PV:
    The stage 1 is Process Design
    Stage 2 is Process Qualification
    and
    Stage 3 is Continues Process Verification.
    And there are total 4 types of Validations
    1. Prospective validation
    2. Concurrent validation
    3. Retrospective validation and
    4. Re-validation,
    Process Validation, Concept, Regulatory Guidance, Challenges and Verification ‎@PHARMAVEN
    Your Queries
    1. What is Process Validation?
    2. What is Continued Process Verification?
    3. What is FDA Guidance?
    What is FDA Guidance on Process Validation?
    5. What is Process Qualification?
    6. What is perfomance qualification?
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ความคิดเห็น • 21

  • @jigneshpatel1894
    @jigneshpatel1894 3 หลายเดือนก่อน

    Good imformation give u Sir👍👍

  • @MuhammadHaroon-lz6xf
    @MuhammadHaroon-lz6xf 4 หลายเดือนก่อน +1

    Excellent explaination

    • @PHARMAVEN
      @PHARMAVEN  4 หลายเดือนก่อน

      Glad it was helpful!

  • @msd6178
    @msd6178 ปีที่แล้ว +2

    Very clear explanation sir.. Thank you for sharing value information

  • @rgcoll9588
    @rgcoll9588 ปีที่แล้ว +1

    Really informative details.... Pls share more vidio related to training...GDP, GMP... Etc

    • @PHARMAVEN
      @PHARMAVEN  ปีที่แล้ว

      Thanks
      I will make
      Please also help me in spreading knowledge by sharing these knowledge videos to all your friends and groups and juniors

  • @avinashkadam6745
    @avinashkadam6745 ปีที่แล้ว +1

    Thank you sir explained in very lucid way. Please explain types of process validation and which approach company follows nowadays.

    • @PHARMAVEN
      @PHARMAVEN  ปีที่แล้ว

      Prospective validation is most followed approach. This approach, we do validation first then commercial production
      Concurrent validation which is not preferred by FDA is ongoing validation during commercial production
      Earlier third approach called retrospective validation where data of old batches were being used to prove that process is Valid. This approach is no more valid now and no one uses it, not allowed by FDA.

  • @PharmGrow
    @PharmGrow ปีที่แล้ว +1

    Very nicely explained 👍

    • @PHARMAVEN
      @PHARMAVEN  ปีที่แล้ว

      Thanks a Lot, kindly also share to your friends and groups and juniors 🎉

  • @sivakella8581
    @sivakella8581 ปีที่แล้ว +1

    Pls Explain compounding vessels validation process and its criteria sir

  • @nirmalsartana4061
    @nirmalsartana4061 ปีที่แล้ว +1

    Very nice sir

  • @Pharmainform
    @Pharmainform ปีที่แล้ว +1

    great

    • @PHARMAVEN
      @PHARMAVEN  ปีที่แล้ว

      Thanks a Lot, kindly also share to your friends and groups and juniors 🎉

  • @adityabhatia1862
    @adityabhatia1862 8 หลายเดือนก่อน +1

    Sir any videos on Change control system?

    • @PHARMAVEN
      @PHARMAVEN  8 หลายเดือนก่อน

      I have uploaded
      th-cam.com/video/G7Eqc_HIc50/w-d-xo.htmlsi=EyLcOKK2Hea8mx3X

  • @Robby2vlogs
    @Robby2vlogs ปีที่แล้ว +1

    hattsoff

    • @PHARMAVEN
      @PHARMAVEN  ปีที่แล้ว

      Spread the knowledge 🎉🙏

  • @AmitSolankii451
    @AmitSolankii451 6 หลายเดือนก่อน +1

    Good explanation Sir

  • @subhraprakashchakraborty8326
    @subhraprakashchakraborty8326 10 วันที่ผ่านมา +1

    can i take deviation in validation batches if my pre defined parameter deviates in process validation batch

    • @PHARMAVEN
      @PHARMAVEN  10 วันที่ผ่านมา

      What parameters are deviated?