GMP Guidelines for Pharmaceuticals

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  • Опубліковано 4 січ 2025

КОМЕНТАРІ • 31

  • @seemakurthisureshbabu4133
    @seemakurthisureshbabu4133 3 роки тому +1

    Your regulatory ka baap....sir
    Your my ideal sir

  • @snwani9109
    @snwani9109 4 роки тому +1

    It was Quite informative vedio,
    Sir please make a complete vedio session on training which includes, job specific training, self training, approved trainer, qualification of approved trainer, training calender, training matrix , effectiveness of training and all that. Effec

  • @sargamdhanishtha249
    @sargamdhanishtha249 5 років тому +1

    Well done 👍

  • @ajinathhajare3416
    @ajinathhajare3416 5 років тому +1

    Nice sir..

  • @nimeshtamboli1870
    @nimeshtamboli1870 4 роки тому +1

    how to determine training effectiveness check.

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  4 роки тому +1

      We can make a formal procedure for training effectiveness check. We can make use of checklist, self inspection, spot checks etc.

  • @headqa2147
    @headqa2147 5 років тому +1

    Superb sir

  • @annu6284
    @annu6284 3 роки тому +1

    Sir can u provide details regarding WHO GMP violation , case studies

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  3 роки тому +1

      Sure. Will take as a separate session

    • @annu6284
      @annu6284 3 роки тому

      @@hitendrakumarshah3718 sir can u give examples of WHO gmp violation cases...i am in urgent need of this info

  • @aryanpant982
    @aryanpant982 4 роки тому +1

    sir is there any diffrence between pharmacopeia and guideline.
    means pharmacopeia can be guideline because so many time i came across with the person who call pharmacopeia as guideline

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  4 роки тому +1

      Pharmacopeia consist of monograph which should be followed while testing. For example, if you are manufacturing product for US, and if the product monograph is available in USP, you are supposed to follow USP. While the guideline provided recommendations on that basis, we can develop our internal procedure (SOP) and can follow. Hope you are clear. If further any question, please comment.

    • @aryanpant982
      @aryanpant982 4 роки тому +1

      @@hitendrakumarshah3718 sir please provide 1 entire session of training on OOS because it is so much confusing and i have tried so much to get the concept that what we can do and what we cant during inbestigation but i never got these points clear ...
      please sir..

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  4 роки тому +1

      @@aryanpant982 Sure. Will consider OOS also

    • @aryanpant982
      @aryanpant982 4 роки тому +1

      @@hitendrakumarshah3718 thank you sir ..you are helping us because there are so many things which are very confusing ...a very big thanks

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  4 роки тому +1

      aryan pant welcome. Please keep learning

  • @kiranyekula6302
    @kiranyekula6302 3 роки тому +1

    Sir kindly make a vedeo, how many sections and sub sections in every regulatory guideline I.e fda, who, eu gmp, mhra....

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  3 роки тому +1

      I understood your question. I will prepare separate session on it. Which will include all different guides and how to access them.

    • @kiranyekula6302
      @kiranyekula6302 3 роки тому +2

      @@hitendrakumarshah3718 once again I strongly request you, so many people knows ich has 4 sections q,m,e,s again q has 14 sections, but so many people dont know about other regularly guidlines , please sir iam eagerly waiting for your reply

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  3 роки тому

      @@kiranyekula6302 Yes dear. I will not only prepare on one guide but need to prepare completely for ANVISA,TGA,TPD,Schedule M, 21CFR, PIC/S and many more...

  • @proogamerop5266
    @proogamerop5266 5 років тому +1

    Nice