EU GMP Audit

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  • #5633
    Ashiqur
    Participant

      What are the most critical check points for facing EU GMP audit?

      #5644
      aid
      Participant

        Hi Ashiqur!
        Here is the top 10 check points for facing EU GMP audit:

        1. Job Training
        2. Quality Policy
        3. Good Housekeeping Program
        4. Equipment Qualification and Calibration Program
        5. Cleaning Validation
        6. Test specification and control
        7. Inventory and Vendor Control Program
        8. Process Validation Program
        9. Reprocessing/ Reworking Procedure
        10. Complaint Handling and Customer Satisfaction Program

        The above list is not complete but will be important for audit preparation.

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