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Quality risk analysis in a cGMP environment: multiple models for comprehensive failure mode identification during the

Brian Gervais1, Deirdre M D'Arcy

  • 1Rottapharm Limited , Dublin , Ireland.

Drug Development and Industrial Pharmacy
|December 11, 2012
PubMed
Summary

Failure mode and effects analysis (FMEA) improved pharmaceutical quality systems by integrating human error prediction and hierarchical modeling. This enhanced risk analysis proactively identifies and mitigates potential failures before they impact patients.

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Area of Science:

  • Pharmaceutical manufacturing
  • Risk management
  • Quality systems engineering

Background:

  • Pharmaceutical quality systems rely on historical failure data, limiting proactive risk mitigation.
  • Risk analysis techniques offer potential for predicting and preventing quality failures.
  • Failure Mode and Effects Analysis (FMEA) is a risk assessment technique of interest to the pharmaceutical industry.

Purpose of the Study:

  • To implement and evaluate FMEA for a computerized manufacturing execution system in pharmaceutical production.
  • To identify limitations of FMEA in predicting certain failure types, particularly human error.
  • To enhance FMEA by integrating complementary risk analysis techniques.

Main Methods:

  • Applied FMEA to a computerized manufacturing execution system implementation.
  • Monitored the system post-implementation to detect and analyze unpredicted failures.
  • Integrated Hierarchical Holographic Modeling (HHM) and adapted event trees from the Technique for Human Error Rate Prediction (THERP) to supplement FMEA.
  • Used identified failure modes from HHM and THERP as input for FMEA prioritization and mitigation.

Main Results:

  • FMEA alone demonstrated weaknesses in predicting non-hardware risks like human error, confirming findings from other industries.
  • HHM identified additional potential failure modes not initially covered by FMEA.
  • Adapted THERP event trees revealed further human error scenarios.
  • The integrated approach significantly strengthened the FMEA by broadening the scope of considered failure modes.

Conclusions:

  • FMEA's effectiveness in pharmaceutical risk analysis can be substantially improved by incorporating techniques like HHM and THERP.
  • A hybrid approach combining FMEA with HHM and THERP provides a more comprehensive risk assessment for pharmaceutical manufacturing.
  • Proactive identification and mitigation of a wider range of potential failures, including human error, enhance pharmaceutical quality systems and patient safety.