The Contamination Control Strategy (CCS), introduced by the draft Annex 1, is a culmination of an exercise to identify activities designed to prevent microorganisms, pyrogens, and particulates contamination in the product, the facility, and supporting processes used to manufacture the product. Manufacturers can formulate their contamination control strategy based on information in the quality target product profile or in the critical quality attributes, in the facility and in the processes used to manufacture and transport the product. The strategy implementation involves executing the strategic plan and managing the implementation by priority overtime should it be deployed. The evaluation of 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/controls to achieve the desired result, minimizing the contamination risk.
The presentation goal is to propose an implementation roadmap of a Contamination Control Strategy (CCS). The topic of focus will be around cleaning and disinfection and sterility assurance level as one of the elements to analyze. The presenters will help in defining the set of controls needed to assess the performance of the CCS in these regards.
- Walid El Azab, STERIS
- Aaron Mertens, STERIS
- Daniel Klein, PENDING
Why Should I Attend?
At the end of the presentation, attendees will understand the CCS implementation roadmap and the information needed to:
- Formulate a CCS
- Implement a CCS and develop a strategic plan to make the strategy work as intended by mapping/designing the organizational structure, procedures, control processes, distributing resources, developing the decision-making processes, etc.
- Evaluate the CCS efficiency to ensure process performance and product quality while improving the CCS level over time.