Good Clinical Practice Guide
Results 1 to 2 of 2

Thread: Audits

  1. #1
    Forum Member
    Join Date
    Nov 2011



    What are the requirements for auditing laboratories that perform the storage and analysis or evaluation of clinical trial samples?
    Can this be done via an audit checklist followed up by an onsite audit if neccessary?

  2. #2
    Forum Member
    Join Date
    Nov 2011
    Refer to guidance document published by MHRA. It is an excellent guide detailing enough info to stay compliant with the regulations.
    Audit checklists are brilliant, but don't make the habit of sticking to your checklist only. The problem I observed is that if you stick to the checklist there is a risk that you focus on minute things and don't look at the bigger picture.

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts