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  1. #1
    Validation Guru
    Join Date
    Oct 2010
    Location
    Copenhagen,Denmark
    Posts
    1,798

    Default Mlt validation protocol

    Please find attached MLT Validation Protocol.
    This is a ready to use document and you can make necessary changes.
    This was prepared keeping in view regarding the latest harmonization guidelines.
    If you have any comments you can post your comments and update the document too to support your proposed updates.
    Regards
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    Durga Prasad

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  3. #2
    Validation Expert
    Join Date
    Jun 2011
    Posts
    61

    Default

    Dear Sir,

    Thank you very much for sharing with us a precious document.

    Usually Environmental monitoring conducted using settle plates exposed for four hours with Soybean casein agar media but this method was not validated. Now we want to validate the procedure by adding glycerine act as a humectant in the agar to prevent desiccation. Because of the very low relative humidity often experienced in winter.

    Can you suggest us how to approach the validation in this view. How to optimise the concentration of glycerine to be added in media? What are the points to be considered during the validation and optimise the concentration of glycerine to be added in media.

    We are looking anxiously for your help in this view...

    Thanks in advance.

    Pulla Reddy Karnati

  4. #3
    Validation Analyst
    Join Date
    Dec 2013
    Location
    Armenia
    Posts
    6

    Default

    Dear Durga Prasad
    Could you please, also attach a method validation report form example? It would be a great help for me.
    Best regards

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