Abstract
Product knowledge grows and evolves during the life of a product. In order to maintain a state of control and deliver product with consistent quality throughout its commercial life, continuous improvement and product lifecycle management become essential. The practical link between product and process knowledge, risk-based control strategies, and continual improvement and innovation can be made stronger through evidence-based risk reduction. This paper introduces the concept of evidence-based risk reduction within the continual improvement framework. It presents how regulatory relief and flexibility in post-approval change management and overall product lifecycle management can likely only be achieved via (1) effective application of science and risk-based concepts and (2) demonstrated effectiveness of the pharmaceutical quality system in assuring a state of control.
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- Article
- Abstract
- Introduction
- Practical Implications
- Risk Management and Knowledge Management
- Role of the Pharmaceutical Quality System (PQS)
- Estimation of Risk Reduction
- Change Management and Risk Reduction
- Enabling Regulatory Flexibility through an Effective PQS
- Risk Management Learnings from Other Industries
- Conflict of Interest Statement
- Reference
- Figures & Data
- References
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