In-Process Controls (IPCs) for DSP in cGMPs

This activity introduces the role of In-Process Controls (IPCs) within DSP operations, explaining how they help ensure real-time quality, traceability, and compliance of biological products. It presents the main categories of IPCs—physicochemical, microbiological, and biochemical—their relationship with Critical Quality Attributes (CQAs), and the associated regulatory and operational challenges.

This activity explores the main physicochemical, microbiological, and biochemical control methods used during processing, along with the associated equipment. It highlights best practices in sampling and the precautions needed to ensure reliable results and compliance with cGMP requirements.

This activity trains learners to identify deviations based on control data found in batch records or procedures, and to respond appropriately to out-of-specification (OOS) results. It promotes a proactive approach to deviations by incorporating CAPA principles and continuous improvement practices.