In-Process Control Testing

In-process control (IPC) tests are now the most widely used tests/criteria to monitor the progress of the manufacturing of active pharmaceutical ingredients (APIs) and intermediates, yet a systematic approach for IPC analysis has been lacking. This chapter is a summary of the current strategies and technologies used for IPC analysis. Pharmaceutical API process controls are reviewed in detail, and typical IPC tests are summarized. A sample plan is established with specific recommendations for IPC method development, sample handling, and execution. Detailed recommendations are described for the above tasks. The details of different types of IPC analyses are also categorized, including completion of reactions, impurity determinations, solvent exchanges, and product isolation end points. The validation of chromatographic IPC tests is summarized in detail. The early development and commercial manufacture IPC methods, which encompass different transfer strategies, will also be discussed.