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2015/2016 Quality Risk Management Benchmarking Survey.

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Summary

Pharmaceutical and biopharmaceutical industries are halfway to full quality risk management (QRM) maturity. Continued progress is needed to fully realize the business and quality benefits of QRM.

Keywords:
EffectivenessICH Q9MaturityQRMQuality risk managementRisk management

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Area of Science:

  • Pharmaceutical Science
  • Biopharmaceutical Science
  • Regulatory Science

Background:

  • Quality Risk Management (QRM) is crucial for medicinal product quality and patient safety.
  • ICH Q9 guideline promotes QRM principles, moving beyond basic compliance.
  • Full realization of QRM benefits requires enhanced maturity in industry practices.

Purpose of the Study:

  • To investigate Quality Risk Management (QRM) maturity in the pharmaceutical and biopharmaceutical sectors.
  • To analyze the effectiveness and efficiency of current QRM programs.
  • To benchmark QRM adoption against industry best practices.

Main Methods:

  • Utilized results from a 2015-2016 QRM benchmarking survey.
  • Analyzed data from pharmaceutical and biopharmaceutical industry practitioners.
  • Assessed QRM maturity beyond "check-the-box" compliance.

Main Results:

  • The pharmaceutical and biopharmaceutical industries are approximately 50% mature in QRM adoption.
  • Significant progress in QRM application has been observed over the last decade.
  • The full value of QRM in business and quality operations is yet to be achieved.

Conclusions:

  • The industries have made substantial advancements in quality risk management.
  • Further development is necessary to reach optimal QRM maturity.
  • Enhancing QRM maturity will unlock greater business and quality operational value.