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…)
