Auditing as A Management Tool in Pharmaceutical Companies (Review Article)

Author(s): Sindhuja Kannan, Shabna Roupal Morais, S. Prema* and K. Chitra

Abstract: 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 program.

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