REVIEW ARTICLE ON QUALITY AUDIT IN PHARMACEUTICAL ANALYSIS

Quality audit is a key management tool for monitoring the suitability of a company’s quality management system and in driving continuous improvement leading to Good manufacturing practice compliance and inspection readiness. Conducting internal audits and external audits of suppliers and outsourcing operations are key elements of a good quality system. Auditing in the pharmaceutical sector serves two different categories: regulatory compliance and business needs. By establishing a high-quality audit system throughout the industry, the level of compliance will increase. This article explores the establishment of an auditing program for both internal audits and external audits including key elements to address when implementing an auditing programAuditing is a dynamic part of any pharmaceutical companies. Quality Audit is analysis and appraisal of all quality assurance program and quality control program to ensure its quality. It is one of the way to examine pharmacy program and make sure that procedures, compensation comply with regulatory and GMP requirements. Quality audit is usually operated by external experts or by a team selected by management of pharmaceutical companies. An audit will appraise strength and weakness of quality assurance processes, the result will help in improving the process and also build better system for company benefits. Pharmaceutical audits includes from design qualification upto performance qualification steps. It also included SOP, guildliness, validation policies.

Keywords: Audit; Internal audit; SOP; Nonconformitites; Defects