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Transformation in the pharmaceutical industry: transformation-induced quality risks--a survey
Nader Shafiei1, James L Ford, Charles W Morecroft
1School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, UK.
PDA Journal of Pharmaceutical Science and Technology
|June 12, 2013
Summary
This study validates pharmaceutical quality risks and defines a risk model using expert opinion. The model shows transformation risks significantly impact regulatory compliance post-development.
Area of Science:
- Pharmaceutical industry
- Quality risk management
- Regulatory compliance
Background:
- Ongoing transformation within the pharmaceutical sector necessitates a thorough understanding of its impact on product quality.
- Previous research identified key transformation triggers and proposed associated quality risks.
- Validating these risks and defining a comprehensive quality risk model is crucial for industry stakeholders.
Purpose of the Study:
- To validate proposed pharmaceutical quality risks through expert opinion elicitation.
- To define a resultant quality risk model based on validated risks.
- To assess the relationship between quality risks and regulatory compliance outcomes across the product lifecycle.
Main Methods:
- Expert opinion survey utilizing a questionnaire.
- Participants possessed recognized expertise in pharmaceutical regulation, product lifecycle, or technology.
- Analysis of survey responses to validate theoretical and operational evidence.
Main Results:
- Survey results validated the four main pharmaceutical transformation triggers and associated quality risks.
- The defined quality risk model demonstrated a strong link between pharmaceutical quality risks and regulatory compliance during marketing approval and post-marketing phases.
- A weaker relationship was observed between quality risks and regulatory compliance during the pre-market evaluation phase.
Conclusions:
- The study successfully validated proposed quality risks and established a quality risk model.
- Pharmaceutical transformation-related risks have a substantial impact on regulatory compliance, particularly in later stages of the product lifecycle.
- The findings provide valuable insights for managing quality risks in the evolving pharmaceutical landscape.
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