ROCCO DURAN
NSF International, 789 N. Dixboro Road, Ann Arbor, MI 48105 USA

Abstract

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.

INTRODUCTION: THE NEED FOR ESTABLISHING AND MAINTAINING EFFECTIVE QUALITY SYSTEMS

Companies need to have the capacity to manufacture products or offer services that are consistently and reliably safe and effective. Since safety and efficacy are fundamental and paramount, there is a necessity for the establishment and maintenance of quality systems across industries, including pharmaceutical, biotechnology and chemical, among others. The establishment and maintenance of quality systems, if implemented correctly, can lead to processes that operate in a state of control, and products that meet specifications while at the same time decreasing the effort and need for extensive periodic monitoring, including fewer audits.

The International Conference on Harmonization, a tripartite effort between the US, Japan and the European Union has published a guidance document on pharmaceutical Quality System (ICH Q10) (1) which has been endorsed and supported by global regulators including the U.S. Food and Drug Administration (FDA) (2) and the European Medicines Agency (3) as recommended guidance towards the industry’s effort in implementing and meeting cGMP†...