CAPA Posts

The Pharmaceutical Industry Still Struggling with CAPA as Part of Overall Quality Management System

One of the biggest challenges for pharmaceutical companies is to complete investigations and actions in a timely manner. In 2009, ICH Q10 adopted by the FDA as an industry guideline, names pharmaceutical Quality Management Systems as a necessity to detect and evaluate non-conformances and take respective corrective and preventative actions. Although it takes time, an efficient CAPA process is an effective tool that can significantly improve quality systems and processes. (more…)