Regulatory Open Forum

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  • 1.  Site Master File (Health Canada)

    Posted 27-Oct-2011 11:33

    We will be submitting a Site Master File to Health Canada as per regulations.  Does anyone have experience with putting one together and comments they might have received from HC about the information submitted? 

    Thank you!

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    Alison Trado
    Regulatory Affairs Manager
    Hill Dermaceuticals, Inc.
    Sanford FL
    United States
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  • 2.  RE:Site Master File (Health Canada)

    Posted 28-Oct-2011 10:22
    Health Canada is a member of PIC/S. PIC/S has a thorough guideline and template for Site Master Files. By following these guidelines you should develop a SMF that is suitable not only for Canada but also for most other countries.

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    Bem Atsma RAC
    Principal Associate
    Canada
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    Original Message


  • 3.  RE:Site Master File (Health Canada)

    Posted 29-Oct-2011 16:50
    Thanks for that information Bem as very helpful.  I had heard of that group, but not gotten on their website and they have good information there.  Thanks.

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    Richard Vincins RAC
    Vice President, QA
    Emergo Group Inc
    Austin TX
    United States
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    Original Message


  • 4.  RE:Site Master File (Health Canada)

    Posted 28-Oct-2011 10:31
    Hi Alison,

    I would first verify (and perhaps you have), that you really need to prepare and submit a Site Master File to Health Canada, ie., you have a scheduled inspection date from the Health Canada Inspectorate.  (I have known sponsors to sometimes spend significant time & money preparing these under the assumption that they are compulsory, when there are other options for demonstrating GMP compliance.)  

    Just a cautionary note!


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    Stan North
    Stan North Consultation
    http://www.stannorthconsultation.com
    Montreal
    Canada
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    Original Message