Abstract
The article proposes an implementation roadmap of a Contamination Control Strategy (CCS) in a facility. The CCS 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.
- Received October 6, 2020.
- Accepted February 18, 2021.
- Copyright © 2021, Parenteral Drug Association
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