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.

        #6263
        FRD
        Participant

          Is it sufficient to get approval from any EU members for whole EU market?

          #6266
          Pharma Digests
          Pharma Expert

            In the European Union (EU), there are two main routes for authorising medicines: a centralised route and a national route.

            Under the centralised authorisation procedure, pharmaceutical companies submit a single marketing authorisation application to EMA.

            This allows the marketing-authorisation holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorisation.

            EMA’s Committee for Medicinal products for Human Use (CHMP) or Committee for Medicinal products
            for Veterinary Use (CVMP) carry out a scientific assessment of the application and give a recommendation on whether the medicine should be marketed or not.

            Once granted by the European Commission, the centralised marketing authorisation is valid in all EU Member States as well as in the EEA countries Iceland, Liechtenstein and Norway.

            If a company wishes to request marketing authorisation in several EU Member States for a medicine that is outside the scope of the centralised procedure, it may use one of the following routes:
            – the mutual-recognition procedure, whereby a marketing authorisation granted in one Member State can be recognised in other EU countries;
            – the decentralised procedure, whereby a medicine that has not yet been authorised in the EU can be simultaneously authorised in several EU Member States.

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