A failure investigation in pharmaceutical manufacturing is a thorough process designed to examine, analyse, and identify the root causes and contributing factors of failures, deviations, or quality issues encountered within products, processes, systems, or operations. The objective of such investigations is to uncover the underlying issues, weaknesses, or deficiencies that precipitated the failure, evaluate its impact on quality, safety, or performance, and devise corrective and preventive actions to avert future occurrences. This involves meticulous evidence collection, root cause analysis, the implementation of corrective measures, and the documentation of findings to foster continuous improvement and ensure the robustness of manufacturing processes against future failures.
« Back to Glossary IndexFailure Investigation
« Back to Glossary Index