Cleaning Validation

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  • Опубліковано 24 лип 2024
  • This training video will insight on Cleaning Validation - Inspection observations, Visual clean criteria & Solving practical problems during cleaning validation.
    Pharmaguideline, NSF International,LEARNINGPHARMACY.IN
    Cadila, Sanofi,Zydus, AstraZeneca,Mylan,Interview Questions with Sharma Ji,ASK Mechnology,emainfo,Qualistery - GMP Content,easy medical device
  • Наука та технологія

КОМЕНТАРІ • 58

  • @hitendrakumarshah3718
    @hitendrakumarshah3718  4 роки тому +3

    This training video will insight on Cleaning Validation - Inspection observations, Visual clean criteria & Solving practical problems during cleaning validation.

  • @user-ww4vq5ld7b
    @user-ww4vq5ld7b 9 місяців тому +1

    Voice re sound is coming in most of the videos ,if it rectify more advantage to audience

  • @ashishjain412
    @ashishjain412 4 роки тому +1

    Nice video

  • @shahrzadtalebian8086
    @shahrzadtalebian8086 4 роки тому +1

    very informative. I subscribed to your channel and watched most of your videos. Subtitle is always useful. Thanks for adding it. Now I can follow and understand your explanations.

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  4 роки тому

      Thanks and welcome. Keep Learning !!! The video will be available soon on,"Inspection Readiness for computerised systems". You will get notification shortly about it if, you have activated notification icon(BELL) button.

  • @manoharkallapari8765
    @manoharkallapari8765 2 роки тому +1

    Sir plz do videos about cleanability study,DEHT and CEHT

  • @aneeshkumarpatel2811
    @aneeshkumarpatel2811 4 роки тому +1

    A lot of thanks, very helpful.

  • @JC-qu1se
    @JC-qu1se 4 роки тому +2

    Sir i have a query for one cleaning validation.
    If my product concentration is 50 MCG per ml
    And batch size is 275 litre.
    What should is acceptance criteria.

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  4 роки тому

      We can not just evaluate by referring this information. I suggest, you refer our cleaning validation part- II for better understanding. I am sharing link for the same. ua-cam.com/video/zBLqRZ5DXV4/v-deo.html

  • @venugopalsriram
    @venugopalsriram Рік тому +1

    Can you please provide the qualification procedure of person for visual cleaning

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  Рік тому

      You can qualify the person/operator after cleaning and testing the swab or rinse residue.

  • @cosmeticgmp
    @cosmeticgmp 4 роки тому +1

    good work, thanks!

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  4 роки тому

      Thank you so much for your kind appreciation. If you need any support, please feel free to contact me.

  • @MrKrish1029
    @MrKrish1029 3 роки тому

    Is this cleaning validation shall be done with respect to every product on every equipment?? suppose in a non dedicated commercial manufacturing plant product A manufactured 10 batches on a row and for first three bathes company has performed cleaning validation, established dirty equipment hold time and cleaned equipment hold time as well, after product change over product B is going to manufacture in same equipment train which are used earlier for product A, now product A cleaning procedure, dirty hold time and cleaned equipment hold time is applicable for product B or not, please clarify.

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  3 роки тому

      I suggest you to go through below two recorded webinars to get more understanding
      ua-cam.com/play/PLq7ln35Rt1rMN52n2o3t_nH0lpmZShkZ6.html

  • @yashshah8706
    @yashshah8706 4 роки тому +1

    Very nice and helpful.

  • @shivkumarbeenaboina5853
    @shivkumarbeenaboina5853 3 роки тому +1

    Dear sir please make a brief video on environmental monitoring program in formulation (injectable).

  • @PankajSharma-ym4je
    @PankajSharma-ym4je 3 роки тому +1

    Helpful video sir, please provide information about CV for TF

  • @myfriends446
    @myfriends446 4 роки тому +1

    Good explanation Sir...

  • @mahendrasinhchavda3948
    @mahendrasinhchavda3948 2 роки тому +1

    Sir very useful video for me 👌

  • @PankajSharma-ym4je
    @PankajSharma-ym4je 3 роки тому +1

    Sir TF means Topical formulation, how calculate MACO for all criterias for TF

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  3 роки тому

      I suggest, you can go through complete cleaning validation package. You will get information on all sort of dosage forms.If you have any questions, please feel free to comment. Will revert you. You can access the cleaning validation package through the link below;
      ua-cam.com/video/zA5xsWR9IU8/v-deo.html

  • @MohsinKhan-ix9ws
    @MohsinKhan-ix9ws 4 роки тому +2

    Respected sir plz make video on audit trail and it's compliance and how to check audit trail

  • @venkatakrishnaanil
    @venkatakrishnaanil 4 роки тому +1

    Good presentation

  • @shobhalatha5048
    @shobhalatha5048 4 роки тому +1

    Informative and helpful for professionals
    Post DI Issues Videos

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  4 роки тому +1

      Sure. The upcoming video will be DI issues and audit trail compliance. Thanks for your suggestion

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  4 роки тому

      Hope, you watched the DI video.
      ua-cam.com/video/YUszNGe6Uyk/v-deo.html

  • @abhijeetgaikwad4202
    @abhijeetgaikwad4202 4 роки тому +1

    Will you provide IPQA whole resposibilities

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  4 роки тому

      The responsibilities are inprocess at shop floor, evaluate critical process parameters, evaluate cleaning activities and give line clearance before going ahead for new product so as to protect the next product from contamination. Now a days, IPQA role is considered as Quality facilitator.

  • @gauravsharmamtvnlvideos
    @gauravsharmamtvnlvideos 4 роки тому +1

    Sir, please give the training about how to do cleaning validation as per fda guidelines

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  4 роки тому +1

      Dear Gaurav, I will really like to take training on this topic, if approximate 10-15 participants are available. Request you to check with your subordinates and friends. Please confirm.

    • @ashishjain412
      @ashishjain412 4 роки тому +2

      @@hitendrakumarshah3718 I am interested for cleaning validation topic

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  4 роки тому

      @@ashishjain412 Sure. We will take up this topic as well.

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  4 роки тому

      @@ashishjain412 We will plan next week for online training(webinar) on cleaning validation.

  • @shailendra1277
    @shailendra1277 4 роки тому +1

    Excellent Hitendra.

  • @Vishalchaurasiabpharm
    @Vishalchaurasiabpharm 4 роки тому +1

    How to perform for vaccine

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  4 роки тому

      For cleaning validation after vaccine product, we need to evaluate what factors will impact on next products e.g. antigens of previos virus vaccines, the chemicals used for attenuation etc. We need to evaluate traces of these antigens or chemicals. It all depends on process followed. If you specify in detail, can guide you in better way.

  • @akashrathore8630
    @akashrathore8630 4 роки тому +1

    Needed good editing

  • @DineshYadav-ni2cm
    @DineshYadav-ni2cm 3 роки тому +1

    For general cleaning watch below presentation, then after CV,
    ua-cam.com/video/xv8rwmKe0Ok/v-deo.html

  • @shirishareddyvlogskurnool6605
    @shirishareddyvlogskurnool6605 3 роки тому +1

    Voice was dnt good ....pls request before taking vidoe pls make ensure and do it all

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  3 роки тому

      You are right. In this video, I have not used collar mike hence resulted in to some echo. After this video, I started using collar mike.

  • @yogeshkhule5456
    @yogeshkhule5456 4 роки тому +1

    Nice video