Good Clinical Practice Guide
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Thread: Accompanying inspectors

  1. #1
    Forum Member
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    Aug 2012
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    Accompanying inspectors

    Has anyone heard of MHRA inspectors being accompanied on an inspection?

  2. #2
    Forum Member
    Join Date
    Nov 2011
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    Accompanied by whom? Their partners? The Police? Enforcement agency officers? EMA Inspectors? FDA Inspectors? Trainee MHRA Inspectors? I think we need more detail

  3. #3
    It is not uncommon for the GCP Inspectors to be accompanied on inspection and there may be a variety of reasons for this.

    Other people attending an inspection could be:
    - MHRA Enforcement officers
    - Police Officers
    - Other MHRA Inspectors (and therefore may incur a fee depending on their role during the inspection)
    - Other MHRA staff
    - Inspectors from other countries
    - Observers from other connected organisations

    European Directive 2005/28/EC also permits the member state to appoint experts with appropriate qualifications and experience to fulfil
    the requirements necessary for conducting the inspection.

    The lead inspector will be happy to discuss the presence of an observer at the inspection.

    For the majority of people attending an inspection it is common that they are there to observe the work of the inspectorate rather than that of the organisation being inspected.

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