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Compliance Services

Compliance Services

QP batch disposition represents the link between the manufacturing and distribution processes, but it is the tip of the iceberg in relation to the efforts taken by companies in order to ensure that the QP can declare that each batch is in compliance with the marketing authorisation.

Compliance Management offers a Compliance Service which facilitates this system of assurance, and our Team can facilitate or manage key activities such as:

  • Change Control
  • Management of variations to the marketing authorisations
  • Assessment and sign-off of deviations
  • Changes to packaging/material specifications
  • Management of customer complaints
  • Problem Investigation and Solving
  • Management of CAPA
  • Management of audit or self-inspection observations
  • Review of validation protocols and reports