![]() The signal is used to automatically regulate the addition of a base or acid (or the controls of CO 2 for mammalian cells). The most classical example of PAT applied to bioprocesses is the maintaining of culture pH at a pre-defined set-point based on an in-situ electrochemical sensor signal. Measuring quality parameters in manufacturing and production starts with monitoring of several common process parameters. The goal is process validation that ensures the safety and efficacy of the pharmaceutical products. Often this involves defining a design space and leveraging design of experiments (DoE) studies. They also play a pivotal role in risk assessment, risk analysis, quality risk management, all of which foster a spirit of quality by design.ĬPPs are essential as process engineers optimize the entire process by which raw materials are converted to desired outputs. ![]() Reliable monitoring of CPPs provides the foundation for process knowledge, process control, quality control, and control strategies. Physical and chemical CPPs are commonly monitored using in-line/on-line process sensors or at-line process analyzers.ĬPPs are covered extensively in FDA guidances, especially the Process Analytical Technologies framework, and the European Medicines Agency’s ICH Q8 (R2). Knowledge Base (Articles, FAQs, Downloads)Ī Critical Process Parameter (CPP) is a term used in pharmaceutical production for process variables which have an impact on a critical quality attribute (CQA) and, therefore, should be monitored or controlled to ensure the drug product obtains the desired quality. ![]()
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