By: Roger Nosal, Chair, Pharmaceutical Engineering Committee

ISPE Pharmaceutical EngineeringLike other regulated businesses, the pharmaceutical industry is focused on appropriately managing risk. From the facilities we construct to the regulatory submissions we make, our ability to address and manage risks can be translated into confidence in quality. Once that confidence is earned and sustained it can be a competitive advantage; however, failure to manage risks can and often does result in rapid loss of confidence.

Everyone sees risk differently. For some the word “risk” conjures images of hazards and dire consequences. For others the word “risk” poses a challenge.

In all cases, one’s perception of risk is intuitively defined by rational doubt and/or irrational fear, primarily based on individual experience.

In the pharmaceutical business, dealing with risk is inherent in the development, manufacture and maintenance of medicines on the market. There are no absolutes. The risks associated with pharmaceuticals largely govern the work required to demonstrate and ensure product quality. While science certainly provides a reasonable level of confidence, the element of uncertainty forces us to make judgments based on our collective experiences.

In 2015, Pharmaceutical Engineering will focus each of its issues on various elements of risk with particular emphasis on strategies for assessing and managing risk with respect to various aspects of pharmaceutical development and manufacturing. We’re proposing the following focus areas for each issue:

Focus Areas

Definition of Risk

  • General Approach to Risk in Accordance with QRM (ICH Q9)
  • Risk Assessments – Prospective vs. Retrospective
  • Risk as a Function of Product Lifecycle
  • If a Risk is Mitigated by a Control is it Still a Risk?
  • Retrospective Risks – Legacy Products

Applying Quality Risk Management to Product Development and Pharmaceutical Manufacturing

  • Risks Associated with Supply Chain Complexity
  • Residual Risk
  • Minimizing Risk through Introduction of RTRt, Continuous Processing, etc.
  • Managing Risks for Expedited Regulatory Submissions – Breakthrough Therapy Designation
  • Risk Associated with Clinical Protocols

Risks Associated with Manufacturing Facilities

  • How Manufacturing Plant Design can Mitigate Risk?
  • Mitigation of Risks for Sterile Manufacture
  • Environmental Risks

 Risks Associated with Pharmaceutical Quality Systems

  • Lifecycle Change Management
  • Knowledge Management – Risk Assessments
  • Site Transfers
  • Quality Metrics
  • Risks Associated with Product Performance
  • Risks and Absence of Bio-relevance
  • Patient Compliance, Product Compatibility and In-Use
  • Devices

 Risk-Based Regulatory Review

  • Benefit vs. Risk
  • Clinically Relevant Specifications
  • Comprehensive Control Strategy
  • Regulatory Commitments and Post Approval Change Management Protocols

We encourage readers and members of ISPE to contribute relevant articles for each of these focus areas. For more information, please visit the Pharmaceutical Engineering   online submission page.