Good Manufacturing Practices (cGMP): When Do They Apply?

By Amanda Bourgeois, Associate Director and Leslie Paul, Associate Director

The application of current Good Manufacturing Practices (cGMP) regulations during the development of a new drug can be a source of uncertainty for clinical project teams. Commencing the incorporation of cGMPs in the drug development process from its inception serves a dual purpose: safeguarding the well-being of clinical trial participants and establishing a sturdy foundation for a comprehensive quality management system (QMS). Embracing quality systems at an early stage facilitates a seamless assimilation of processes, alleviating organizational burdens. Moreover, this proactive approach guarantees enhanced oversight, fosters a culture centered on quality, and mitigates the likelihood of noncompliance. This proactive stance not only aids the organization in its progression toward commercialization but also acts as a vital assurance for a successful pre-approval inspection.

In this article, the author explores expectations set by the U.S. Food and Drug Administration (FDA) regarding the implementation of cGMP standards for investigational drugs. Understanding these expectations is essential for ensuring the quality and safety of emerging pharmaceutical products.