The Role of Auditing within Quality Management in Pharmaceutical Development

Abstract

The principle of self-assessment allows an organization to achieve key objectives such as verifying compliance with applicable regulations and evaluating the effectiveness of the quality system which must be implemented in order to fulfill the ethical, regulatory, and quality requirements. As the pharmaceutical industry thinks “global, ”as management tries to decrease cost and increase effectiveness and efficiency of operations, it is crucial to maintain competitive advantage without affecting the productivity of research and development (R&D). Regarding total quality management, the role of auditing is a key element of a continuous improvement process which helps achieve the above-mentioned objectives. Within this context, the definition and implementation of internationally harmonized auditing practices can achieve another important goal: The mutual recognition of clinical data.