Over the last decade, there has been a significant focus on increasing process understanding and the implementation of Quality by Design (QbD) to ensure that pharmaceuticals matching a target product quality profile are produced. With the application of QbD, appropriate product quality is ensured through adequate process monitoring and control with the use of Process Analytical Technology (PAT). The objective of PAT is to ensure consistent manufacturing process performance and pharmaceutical product quality by taking measurements during the manufacturing process. A standard framework for PAT implementation in a biopharmaceutical process involves identification of Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs), followed by selection of technologies to monitor and/or control those CPPs within ranges that lead to appropriate values of the CQAs. PAT provides capabilities for in-line, at-line, on-line, and off-line analysis, with in-line and on-line technologies offering continuous real-time process monitoring that facilitates implementation of in-process controls at critical unit operations rather than relying on manual sampling and analysis or end-product testing.
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