1: how can process analytical technology be used throughout process validation, give examples? 2: discuss a quality by design and risk management approach? Utilizing Process Analytical Technology and Quality by Design for Process Validation

Process Validation using Process Analytical Technology.

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). Near Infrared (NIR), spectroscopy and PAT have been applied to monitor changes in temperature, reaction rates, or levels of active pharmaceutical ingredient (API) throughout 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). For process validation, PAT can also be used in conjunction with Quality by Design (QbD), and Risk Management. The QbD systematic approach provides a structured way to design, develop, and. Cont…