Improving pharma and biotech quality systems with fewer audits The link between a well-established quality system and fewer audits

摘要

Pharma and biotech companies need to manufacture products or offer services that are safe and effective. Global regulatory agencies as well as agencies responsible for issuing guidance and setting standards, including the European Medicines Agency and The U.S. Food and Drug Administration (FDA) have endorsed and established a comprehensive quality management system (QMS) approach in alignment with current Good Manufacturing Practice (cGMP) requirements to ensure reliable safety and efficacy of products. Although evaluation and improvement activities are inherent to a well-designed and executed quality management system, companies can relieve the burden on their auditing programs by ensuring that their quality management systems are well planned designed and executed and provide real-time control. In doing so, they can decrease their efforts and reliance on internal audit programs, as well as an audit programs inherent challenges and biases.