In-process control (IPC) samples are part of the quality control strategy used to monitor syntheses of Active Pharmaceutical Ingredients (API). Analyses of these samples are used to provide information that preserves the yield and the quality of the process. The primary goals of analytical technology transfer (TT) are the transferral of knowledge and demonstration that the methods used for these analyses have comparable performance when operated by the receiving laboratory.In this presentation, we describe how to use the principles of risk management to define the appropriate transfer activities based on an assessment of the difficulty of the chromatographic IPC method being transferred. The IPC risk assessment is used to eliminate TT activities that are not critical to the method's execution, performance or knowledge transfer. This allows determination of the method parameters that need to be captured and critically evaluated during the method transfer process.

Risk-based approach to technology transfer of in-process control methods

248th National Meeting (2014)

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