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నైరూప్య

Brief Note on Audit in Pharmaceutical Industry

Alfa A. Jain, Vishal B. Babar, and Amol A. Kulkarni

Auditing 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.