Validating Purified Water Systems with a Lifecycle Approach
By Igor Gorsky
The key to control of any process lies in understanding its variability. How much do we know about variation of our processes or systems, and are we in the state of control? These questions need answers to pursue success in the execution of a pharmaceutical plantﾒs processes. Understanding, detection, response. and control from input through output of variation was a focus of a recent revision to the U.S. Food and Drug Administrationﾒs (FDA) Process Validation Guidance to Industry (1). So how does one go about control of variation? To do that, one has to enable a Risk Management System (3). To be highly effective, a Risk Management System needs to be initiated early on during the design of a process or a system. As shown in Figure 1 (2), the lifecycle of the process is divided into three stages. It is a rigorous application of Risk Management tools during Stage 1 (Process Design Stage) that will help the industry to assess, understand an ultimately control the level of variation in systems and processes.
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