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The validation life cycle
Journal of Parenteral Science and Technology : a Publication of the Parenteral Drug Association
|May 1, 1993
Summary
This paper introduces the Validation Life Cycle, a framework to organize pharmaceutical validation activities. It addresses the need for a cohesive approach to validation processes, enhancing efficiency and effectiveness in medical product manufacturing.
Area of Science:
- Pharmaceutical manufacturing
- Quality assurance
- Regulatory compliance
Background:
- Existing literature details process validation methods but lacks guidance on organizing these activities.
- Pharmaceutical and medical product manufacturers need structured approaches for validation.
- The history of validation in the U.S. pharmaceutical industry provides context for current challenges.
Purpose of the Study:
- To propose a structured framework, the Validation Life Cycle, for organizing validation activities.
- To provide a rational and effective means for achieving organizational validation goals.
- To enhance the understanding of validation process organization in the pharmaceutical sector.
Main Methods:
- Review of existing validation literature.
- Historical analysis of validation practices in the U.S. pharmaceutical industry.
- Development of a conceptual framework for a Validation Life Cycle.
Main Results:
- Identified a gap in organized validation strategies.
- Proposed the Validation Life Cycle as a solution for cohesive validation management.
- Highlighted the benefits of a life cycle approach for validation activities.
Conclusions:
- The Validation Life Cycle offers a mechanism to improve the organization and execution of validation.
- A structured life cycle approach is essential for effective validation in medical product manufacturing.
- This framework aids organizations in meeting validation goals efficiently.