Quality risk management & FMEA

The scope, form and documentation used in quality risk management within the pharmaceutical sector should be suitable for the specific risks in question. This is why Diapharm supports pharmaceutical companies in creating and implementing streamlined, effective Quality Risk Management Systems (QRMS) in line with EU GMP guidelines/ICH Q9, including Failure Mode and Effects Analysis (FMEA).

FMEA in a pharmaceutical QRMS setting

QRMS does not mean FMEA only, but FMEA – Failure Mode and Effects Analysis – does play a key role in all pharmaceutical sector risk management systems. Diapharm’s GMP experts support pharmaceutical companies in identifying risks to product quality and in creating reliable but at the same time streamlined FMEA analyses. Proactively for your planned processes as well as retrospectively for existing processes.

There is another advantage: FMEA enables you to tackle problems in advance and helps reduce unplanned production stops, thereby increasing your overall productivity in terms of GMP.

Our quality risk management services

  • Consulting
  • Process analysis
  • Failure Mode and Effects Analysis (FMEA)
  • Drafting standard operating procedures (SOP)
  • Creating quality risk management plans
  • Staff training


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