In this Audiocast we discusses the common issues that can arise in the pharmaceutical industry, including quality-related issues, adverse events, product complaints, and product recalls. The video provides guidance on how to handle and report these issues, including identifying the problem, conducting a root cause analysis, implementing corrective and preventive actions, and reporting to relevant parties such as regulatory agencies. The video emphasizes the importance of complying with regulatory requirements and keeping detailed records of all aspects of the issue to ensure patient safety.
Quality-related issues, adverse events, product complaints, and recalls are common in the pharmaceutical industry, occurring at any stage of manufacturing. Issues can arise from raw materials, equipment, or processes, leading to contamination, labeling errors, or deviations. Adverse events include allergic reactions and side effects, while product complaints involve problems reported by customers. Recalls involve the voluntary or mandatory removal of products due to safety concerns. Handling and reporting these issues require steps such as identification, containment, root cause analysis, reporting, and record-keeping. Regulatory requirements may vary, so consulting with relevant agencies is recommended.