Cleaning Validation - Key Questions and Answers - III

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  • Опубликовано: 10 дек 2024

Комментарии • 27

  • @ramakrishnaguttula7941
    @ramakrishnaguttula7941 8 месяцев назад +2

    Good training sir

  • @mayurkale5357
    @mayurkale5357 Год назад +2

    Keep it up

  • @music1056
    @music1056 11 месяцев назад +2

    Dear Sir, Please clarify about purging factor and safety factor in case of MACO calculation by ADE Or PDE value

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  11 месяцев назад

      The Safety factor clarification is given in the video. You can go through it - ruclips.net/video/TWADZmMICqo/видео.html
      What is Purging factor? I am not clear. Please share details so that, I can guide you.

    • @music1056
      @music1056 11 месяцев назад

      Dear Sir, I am not asking about safety factor in Case of formula in TDD. I am asking about safety factor which is given maco formula by using HBEL i. e. ADEor PDE value

    • @music1056
      @music1056 11 месяцев назад

      Also in APIC guideline it is mentioned that if it is not known it will be taken as 1

  • @Training-rt3ng
    @Training-rt3ng Год назад +1

    Very Helpful Sir 🙏

  • @mayurkale5357
    @mayurkale5357 2 дня назад

    Sir- Is individual rinse sample acceptable for cleaning validation or verification? Is there any guidelines requirement? Please give the reference of any.

  • @vinayakdumka5247
    @vinayakdumka5247 Год назад +1

    Nice information given

  • @music1056
    @music1056 11 месяцев назад +1

    Dear Sir, Please clarify about Recovery factor in case of Swab limit calculation

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  11 месяцев назад

      Recovery factor is factor which we need to consider as, 100% recovery may not be possible. For detail understanding, you can go through recorded webinars -
      1. ruclips.net/user/live2I_H5SsTSuQ?feature=share
      2. ruclips.net/user/livezBLqRZ5DXV4?feature=share

  • @shailendrapandey2008
    @shailendrapandey2008 9 месяцев назад +1

    Can we manufacture three or more batches without performing product-to-product cleaning when the campaign batch is considered the worst case during cleaning validation?

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  8 месяцев назад

      No. First we need to validate product change over cleaning. Based on the campaagin after this validation we can perform campaign study.

  • @AUDITS-wm2dg
    @AUDITS-wm2dg Год назад +1

    Thank you Sir !!!

  • @smarikapanwar9300
    @smarikapanwar9300 Год назад +1

    Can you please me provide visual residue limits to incorporate cleaning validation protocol?

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  Год назад

      I suggest, you can go through this short video on CV - ruclips.net/video/zA5xsWR9IU8/видео.html

    • @Bharatpithiyalive
      @Bharatpithiyalive Год назад

      Thank you for the knowledge..
      Sir who prepared CV protocol? QA or production?

    • @smarikapanwar9300
      @smarikapanwar9300 Год назад

      @@hitendrakumarshah3718👍

  • @smarikapanwar9300
    @smarikapanwar9300 Год назад +1

    Thanks

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  Год назад

      Welcome. Please share the link of learning video with your colleagues so that, they can also get benefit from this learning.