GMP Cheklist

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  • #5632
    Ashiqur
    Participant

      What are the basic GMP requirements for new manufacturing facility?

      #5646
      aid
      Participant

        Basic GMP requirements for new pharma manufacturing facility:
        – Appropriate design and location,
        – Proper resources: personnel, buildings, equipment, materials,
        – Clearly defined and systematically reviewed processes,
        – Trained personnel,
        – Proper storage and distribution procedure,
        – Internal and external health and safety,
        – Appropriate waste disposal system etc.

        Reference: https://www.pharmaspecialists.com/2022/03/gmp-facility-design-gmp-golden-rules.html

        #5676
        Pharma Digests
        Pharma Expert

          Bekow things should also include for a new GMP facility:
          – Records and Reports
          – Sanitation condition
          – HVAC system
          – Raw material sourcing
          – Internal audit and compliance etc.

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