How to Ensure a Holistic Process Characterization in Biotech & Pharma
Constant, reliable product quality is a must for pharmaceutical and biopharmaceutical manufacturing. Regulatory authorities require drug manufacturers to consistently deliver product quality through validated processes in order to achieve product approval. Process characterization is a central cornerstone and the first stage of process validation (PV). Failing to efficiently plan and execute activities on that stage leads to increased time-to-market. A successful process characterization study (PCS) is key to reduce time-to market of any pharmaceutical and biopharmaceutical product. This can be achieved by following a 7-step model that starts with a process validation plan and leads to an integrated process model and overall control strategy. Learn more in this white paper.