Quality Management Maturity: A Valuable Framework for CDMOs to Strengthen Their Regulatory and Quality Compliance

Introduction

Every pharmaceutical contract development and manufacturing organization (CDMO) knows that quality is essential. But a CDMO should not merely comply with baseline current good manufacturing practices (cGMPs). Instead, it should embrace a holistic quality culture focused on excellence and continuous improvement.

For a CDMO to make this shift from mere compliance to quality excellence, it may be helpful to evaluate its systems through the lens of quality management maturity. The Quality Management Maturity (QMM) program initiated by the US Food and Drug Administration (FDA) in late 2023, provides an excellent framework for understanding what quality looks like at a mature organization, and what companies should consider as they strive to reach that maturity (1). The agency’s prototype assessment protocol suggests five practice areas: management commitment to quality; business continuity; an advanced pharmaceutical quality system; technical excellence; and employee engagement and empowerment (2). Below, we discuss the best practices and expectations for quality management maturity in these five areas.