PDA Survey of Quality Risk Management Practices in the Pharmaceutical, Devices, &amp; Biotechnology Industries

Ruhi Ahmed; Harold Baseman; Jorge Ferreira; Thomas Genova; William Harclerode; Jeffery Hartman; Samuel Kim; Nanette Londeree; Michael Long; William Miele; Timothy Ramjit; Marlene Raschiatore; Charles Tomonto

Abstract

In July 2006 the Parenteral Drug Association's Risk Management Task Force for Aseptic Processes, conducted an electronic survey of PDA members to determine current industry practices regarding implementation of Quality Risk Management in their organizations. This electronic survey was open and publicly available via the PDA website and targeted professionals in our industry who are involved in initiating, implementing, or reviewing risk management programs or decisions in their organizations. One hundred twenty-nine members participated and their demographics are presented in the sidebar “Correspondents Profile”. Among the major findings are

The “Aseptic Processing/Filling” operation is the functional area identified as having the greatest need for risk assessment and quality risk management.
The most widely used methodology in industry to identify risk is Failure Mode and Effects Analysis (FMEA). This tool was most widely applied in assessing change control and for adverse event, complaint, or failure investigations.
Despite the fact that personnel training was identified as the strategy most used for controlling/minimizing risk, the largest contributors to sterility failure in operations are still “Personnel”.
Most companies still rely on “Manufacturing Controls” to mitigate risk and deemed the utilization of Process Analytical Technology (PAT) least important in this aspect.
A majority of correspondents verified that they did not periodically assess their risk management programs.
A majority of the correspondents desired to see case studies or examples of risk analysis implementation (as applicable to aseptic processing) in future PDA technical reports on risk management.

Footnotes

The results from the PDA survey provide insights about industry-wide practices of Quality Risk Management (QRM), which involves identifying areas of criticality or vulnerability for appropriate control, mitigation, and communication of risks.
The authors are members of PDA's Risk Management Task Force. Ruhi Ahmed, Ph.D. is an associate director, Regulatory Affairs at BioMarin Pharmaceutical, Inc.; Harold Baseman is a principal and COO at ValSource, LLC; Jorge Ferreira is the technology manager for Jacobs Engineering; Thomas Genova, Ph.D. is a quality fellow at Johnson & Johnson Global Biological Supply Chain, LLC; William Harclerode is a senior manager, QA at Forest Laboratories; Jeffery L. Hartman is a validation manager, Regulatory and Analytical Sciences at Merck & Co., Inc.; Samuel Kim; Nanette Londeree is a consultant; Michael Long is a senior manager, Manufacturing Technical Services at AstraZeneca; William H. Miele, Ph.D. is a director/team leader for Quality Systems and Technical Services, Microbiology/Aseptic Support at Pfizer Global Manufacturing; Timothy Ramjit is senior director, Global Technical Services at Schering-Plough; Marlene Raschiatore is a director, Global Regulatory Affairs at Wyeth Pharmaceuticals; Iris Rice is executive coordinator, Scientific and Regulatory Affairs, Parenteral Drug Association (PDA); and Charles Tomonto is an engineer fellow, Technology Development at Johnson & Johnson, Cordis.
The views expressed in this Article are the authors' own, and are not necessarily those of BioMarin, ValSource, Jacobs Engineering, Johnson & Johnson, Forest Laboratories, Merck & Co., AstraZeneca, Parenteral Drug Association, Pfizer, Schering Plough, Inc., Wyeth Pharmaceuticals, and Johnson & Johnson, Cordis.
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