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Pharmaceutical Industry’s Maturity in Risk Management: The Big Gap

The pharmaceutical industry has a reputation for making significant investments in risk management. After all, they manage a business with a high level of risk – financial risk from very expensive research programs, reputational risk from testing new compounds on humans, and constant regulatory compliance risk. Mitigating these risks are a core determinant of success, and a quality risk management (QRM) approach that is well understood and commonly accepted is required.
I recently had the opportunity to present at the Institute of Validation Technology (IVT) Quality Risk Management conference, which brought together quality professionals from pharmaceutical companies. One of the hot topics was the industry’s true level of maturity in applying QRM principles. Recent press about poor product quality suggests pharmaceutical companies may not be far along the ‘Risk Maturity Model1‘, and there are many opportunities for improvement.
We explored recent research in QRM2, and trends in compliance enforcement actions – namely FDA warning letters:

  • Drug product recalls from 2006-2013 is increasing
  • Recalls related to product quality is increasing
  • cGMP-related warning letters with 1 or more QRM citations is increasing
  • The majority of QRM citations issued were due to a failure to apply QRM

In looking at the five phases of the Risk Maturity Model, these findings indicate that some pharmaceutical companies are between Phase 1 and Phase 2, where QRM activities are informal, inconsistent, and insufficient.


QRM Model

While not a reflection of QRM adoption in every company, it’s nonetheless a good call to action as quality professionals expand efforts to improve product quality.
To support continuous improvement in quality, please join a quality roundtable with thought leaders on Thursday, May 28, 2015 to discuss how organizations can move up the quality maturity curve with risk management being a key aspect. Look for additional information in the coming weeks.


1. Risk Maturity Model adapted from PDA Technical Report No. 54. PDA Technical Report No. 54. “Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations.” 2012.
2. Quality Risk Management: Diagnosis or Cure?, Kelly Waldron, PhD Researcher, January 25, 2015

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