Every pharmaceutical manufacturer must have and implement suitable processes for dealing with deviations from processes and quality specifications in order to continuously ensure the required quality of the products. There are many reasons for deviations. They range from quality problems in the raw materials, materials, equipment and devices used to inadequate description or implementation…
Managing deviations and investigations efficiently is critical to ensuring product quality, compliance with regulations, and continuous improvement. An effective quality management system (QMS) must include procedures to identify, document, segregate, evaluate, and disposition production and post-production issues. You need to report and document the deviation as soon as it is identified. This includes…
Corrective and Preventive Action (CAPA) was first formally introduced by the U.S. Food and Drug Administration (FDA) in 2006 as a component of the Quality Systems Guidance. This guidance would go on to form the basis of the ICH Q10. Since then, it’s found its way into the EU GMP Guide, laying out the…
Root Cause Analysis (RCA) is a problem-solving methodology that steps you through the RCA process. Each RCA process phase has a range of root cause analysis tools that you can use. The RCA process starts at the problem event then moves through evidence collection, investigation, analysis, developing corrective actions to address the problem or…
