Analytical Incidents In the Pharmaceutical Industry: A Review

ABSTRACT Incidents are Analytical Incidents that occur during analytical testing that affect the quality of the product. This paper includes a study to ensure the quality and safety of drugs and also avoid future incidents. The research is based on the root cause of incidents and their patterns. To overcome these incidents, quality audits are performed. These incidents are important for the following reasons. Product quality: Analytical incidents can impact the quality of pharmaceutical products, which can affect patient safety and efficacy. Patient safety: Inaccurate or unreliable analytical results can lead to incorrect labelling, potency, or purity of pharmaceutical products, which can harm patients. It Ensures compliance with regulatory requirements, such as FDA, EMA, and ICH guidelines. Prevents regulatory actions, fines, or penalties. These incidents prevent financial losses due to retesting, rework, and product recalls. It prevents damage to a company's reputation and brand.&. Maintains customer trust and confidence. The recent research is mainly focused on methods and corrective action used for accuracy, reliability, and consistency of analytical testing. The recent themes are Data Integrity and security, which are used for maintaining digital records in the laboratory. It also includes continuous improvement and digitization, which are emerging new technologies. The main point of this article is to analyse the root cause of Incidents and corrective action taken on these analytical incidents. This topic is interesting because it brings together ethical and technological challenges that affect human health. These analytical incidents investigate the whole process of the pharmaceutical industry. Keywords: Analytical incidents, root cause, Good Manufacturing Practices, Analytical testing, strengths, fishbone diagram