Introduction
Contract Development and Manufacturing Organizations (CDMOs) have become indispensable partners for pharmaceutical and biotech companies seeking cost-effective solutions, specialized expertise, and streamlined processes across the drug development and manufacturing lifecycle. As the demand for CDMO services continues to grow, embracing Quality by Design (QbD) principles is essential for CDMOs to differentiate themselves, mitigate risks, and deliver value-added solutions to their clients. QbD has emerged as a fundamental philosophy driving efficiency, reliability, and regulatory compliance.

Quality by Design: A right approach
QbD represents a proactive and systematic approach to ensure quality is built into every aspect of product development and manufacturing processes. It emphasizes a thorough understanding of product and process variables, risk assessment, and the application of s ... ...