Treffer: Evaluation of Statistical Process Control (SPC) in Pharmaceutical Manufacturing.

Statistical Process Control (SPC) is a vital tool in pharmaceutical manufacturing to monitor, control, and improve production quality. It employs statistical methods to ensure that processes remain within predefined control limits, thereby minimizing variability and ensuring compliance with regulatory standards. This project aims to evaluate the role and effectiveness of SPC in maintaining consistent product quality across pharmaceutical processes such as granulation, tablet compression, and packaging. By reviewing real-time case studies, batch records, trend charts, and process data from validated sources, the project seeks to assess how SPC techniques—like control charts and process capability analysis—contribute to decisionmaking, deviation reduction, and regulatory compliance in Good Manufacturing Practices (GMP) environments. [ABSTRACT FROM AUTHOR]