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Writing & Executing a Software Validation Protocol: Plain and Simple

Writing & Executing a Software Validation Protocol: Plain and Simple


This quick and easy guide describes methods and approaches for writing a validation protocol that can help ensure a thorough validation effort. It also provides some tips and tricks on executing the protocol and documenting the results.

While this book was written primarily for those new to validation projects and the effort required gathering sufficient evidence to support validation claims , experienced folks will likely find nuggets to help improve their efforts.



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  1. 02-21-2012, 01:07 PM #1
    pcmhetre
    pcmhetre is offline
    Validation Analyst
    Join Date
    Jun 2009
    Posts
    32

    Default Humidity control for empty gelatin capsule

    Dear All,

    Is it necessary to store empty gelatin capsule under humidity control, if yes then what is the justification??

    Kindly response on urgent basis.

    Regards

    Prashant Mhetre
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  2. 02-21-2012, 02:42 PM #2
    DURGA PRASAD
    DURGA PRASAD is offline
    Validation Guru
    Join Date
    Oct 2010
    Location
    Kalundborg,Denmark
    Posts
    1,698

    Default

    The ideal humidity is between 45% to 55%.

    If you store in higher humidity the hard gelatin capsules will soften and you will get loads of rejections.There is every possibility that will soften and lose their shape.

    If you store in lower humidity conditions than specified they might get shattered on the machine. The reason is they get slightly smaller in size after losing certain moisture in them.

    Temeperature too is a critical factor. You must store around 20C.

    Regards
    Durga Prasad
    Internal Consultant,Aseptic Process-NNE Pharmaplan
    www.nnepharmaplan.com
    Denmark
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  3. 04-12-2013, 05:48 AM #3
    narukulanaresh
    narukulanaresh is offline
    Validation Analyst
    Join Date
    Jun 2012
    Posts
    5

    Default

    Dear sir,

    How to dispense the empty capsules? Is Dispense the capsules the numbers or weight besis?

    and incase after manufacturing remaining empty capsules,Is return to stores throgh MRN...? OR are distruct the capsules ? plz clarify as soom as possible sir ?


    THANHS IN ADVANCE ,
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