Risk-Based Qualification and Assurance of Quality

Proving assurance is to make certain, provide confidence, and remove doubt or to be free from doubt. In the context of our industry, assurance can be achieved by observation or prediction. Observation or verification is the confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. One is assured that something exists because one can see it, observe it, and test it. If one cannot observe something, then one must predict that it will happen or has happened. Confidence in the prediction of an outcome based on observation or evaluation of sampling is a key element of pharmaceutical PV. Validation and qualification are ways to provide assurance of product quality through assurance of process performance validation, or qualification is confirmation by examination and objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. In other words, validation is a combination of what can be verified and our confidence that even with reduced verification, that condition will still exist. Put another way, validation or qualification is prediction of outcome we cannot fully observe based on conditions that we can observe.

As long as the outcome, in this case product quality, can be observed, assurance is achieved through observation or inspection. However, if the outcome cannot be observed completely or always, then relying solely on observation or inspection would not be effective. For that reason, there needs to be a way to assure the reliability of the performance of the process in order to assure the quality of the outcome. For the process to be reliable and predictable, the systems and equipment that support and perform the process must be reliable and predictable. The systems and equipment must be fit for use and must perform in a manner that will consistently result in the desired outcome. The desired outcome is a process that results in a product of a specified quality and purity, a product that is safe and effective.

Qualification confirms that systems operate in a manner that adequately supports the process. Qualification provides information and observable criteria, including the design, installation, and operation of a system that supports a process, which will be needed to predict the outcome of the process. A qualityrisk-based approach to qualification focuses efforts on those aspects and functions that adversely affect product quality. There may be and there are sound reasons to commission and qualify systems whose functions do not affect product quality. This chapter is not meant to dissuade those efforts. However, this chapter focuses on the efforts required to qualify those functions and conditions affecting product quality.

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