Utilizing Process Analytical Technology and Quality by Design for Process Validation
Process Analytical Technology (PAT) is an approach to pharmaceutical manufacturing that uses real-time data acquisition and process control, enabling the proactive monitoring and control of a product’s quality. This technology can be used in process validation, as it allows manufacturers to detect and correct problems in a timely manner, as well as reduce variability in the process (Khan & Ahmad, 2016). For example, PAT techniques such as Near Infrared (NIR) spectroscopy, have been used to detect changes in the reaction rate, temperature, and levels of active pharmaceutical ingredients (API) during the manufacturing process (Gilliland et al., 2017). Additionally, PAT can be used to identify reactive impurities, control the particle size distribution of the API, and monitor the drug’s degradation and stability (Mangena & Adebayo, 2016). In addition to PAT, a Quality by Design (QbD) and Risk Management approach can be used for process validation. QbD is a systematic approach that provides a structured approach for designing, developing, and. Cont…
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