The FDA and other global regulatory authorities enforce practices that require companies to integrate regulatory compliant Quality Management Systems (QMS), and Risk Management approaches into their operational processes.
The goal is to encourage industry participants to integrate quality by design (QbD) into their products, with the objective of making products safer for the patient. A well-designed quality management system when combined with the manufacturing processes and product knowledge provides the capabilities to support increased safety and continuous process improvements.
Quality management systems provide the necessary framework for the implementation of quality by design practices that regulators are seeking. Furthermore, quality management systems provide regulators with a mechanism of greater transparency in which to peer into the internal workings of an organization and to efficiently assess its overall compliance with GxP requirements. The purpose of this paper is to provide a top-down holistic overview of how pharmaceutical quality systems when properly implemented can help support an organization’s global strategic quality objectives.
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