Gestion du risque qualité selon ICHQ9

We offer custom-made risk analyzes to meet your expectations and those of the authorities.

  • Application of ICHQ3D Directive (elemental impurities)
  • Application of the 19 March 2015 guideline (excipients)
  • Determination of audits frequency
  • Full analysis intervals in case of delegation of control, or reduce testing
  • Risk analysis : Nitrosamines existence
  • Other on request…

Risk Assessment : NITROSAMINES

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