Deviations handling and corrective actions and preventive actions: Case studies for parenteral dosage form

Abstract

In the pharmaceutical industry, each and every activity is done according to standard operating procedures and protocols. Standard operating procedures are the pre-established stepwise instructions to carry out routine operations while protocols are predefined written document used for design and execution of experiments. In the current scenario, pharmaceutical industry wants to manufacture quality product as per good manufacturing practice guidelines. To achieve six sigma qualities, deviations are very important to consider. Deviations have to be addressed, investigated, and based on investigation data, suitable corrective actions and preventive actions are applied for prevention of its reoccurrence. Corrective actions and preventive actions are important part of quality management system. Corrective actions and preventive actions is a system which falls under good manufacturing practice and many International Standard Organization business standards. Corrective actions and preventive actions include route cause analysis for resolving deviation, which includes its cause of identification, and helps to prevent its occurrence in future. Corrective actions and preventive actions is a combination of ideas and tools to correct deviation. Inappropriate initial route cause identification and application of corrective actions and preventive actions lead to extra work, time, and cost. There are some exceptional cases in which corrective actions and preventive actions are not required, for instance one-time deviation, where only corrective actions are done. The corrective actions and preventive actions system improves and maintains processes, procedures, organization, and business in a systematic, organized, well-documented, and actionable way. In this article, case studies of deviations in pharmaceutical industry helped in identification and evaluation of deviation and based on that application, suitable corrective actions and preventive actions are shown which give thorough understanding of deviation and application of corrective actions and preventive actions in pharmaceutical industry. So, corrective actions and preventive actions are not only regulatory requirements but they make good business sense to the pharmaceutical industry.