Description
Contamination Control Strategy Implementation Plan
The Technical Document proposes a contamination control strategy (CCS) implementation plan in a facility. The CCS is the culmination of an exercise to identify activities designed to prevent microorganism, pyrogen, and particulate contamination in the product, the facility, and the supporting processes used to manufacture the product. Manufacturers can formulate their contamination control strategy based on information in the quality target product profile or the critical quality attributes, the facility, and the processes used to manufacture and transport the product.
The strategy implementation involves executing the strategic plan and managing the implementation by priority over time should it be deployed. Evaluating the efficiency and effectiveness of the contamination control strategy implemented is confirmed by analyzing and trending the various quality performance parameters related to contamination control. The strategy evaluation allows the manufacturer to identify a new strategic plan to support improvement goals or new measures and/or controls to achieve the desired result, minimizing the contamination risk.
The content of this Technical Document:
- Definitions
- Abbreviations
- Introduction
- Purpose
- Scope
- CCS Objectives
- Regulatory Requirements
- Regulatory Expectations
- CCS Document Format
- Responsibilities
- Source of Contamination
- Implementation Strategy
- Periodic Review
- Good Contamination control practices
- Conclusion
- References
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