Skip to Content

Evolving Your QMS From GMP to GxP to Streamline Clinical Trial Operations

Unpacking GxP

GxP is a collection of quality guidelines and regulations (GLP, GMP, GDP, GCP, and GPvP) created to ensure that biotech and pharmaceutical products are safe, meet their intended use, and adhere to quality processes during manufacturing, control, storage, and distribution. GxP was established by several agencies, including the Food and Drug Administration (FDA), and encompasses many different standards.

This collection of quality guidelines ensures that regulated organizations comply with specific processes and procedures that determine effective research standards for nonclinical laboratory trials, safe human-patient clinical trials, and commercially available products.

GxP’s guidelines focus on three essential outcomes: traceability, accountability, and data integrity. GxP consists of multiple components, such as (but not limited to):

Why a Company’s QMS Benefits Moving from GMP to GxP

As life science companies begin to move from manufacturing-focused operations into clinical trial oversight, they often begin to outgrow their GMP Quality Management System (QMS). A QMS covers a set of processes focused on achieving quality policy and objectives to meet customer requirements. A strong QMS system fulfills many objectives, like preparing for regulatory submissions, designing an effective validation system, effective audits, establishing good record-keeping practices, and much more.

We often hear from Quality Leaders that “Our Quality procedures are too GMP specific and do not work as we move into the Clinical space.” As companies move from standard manufacturing operations and into first-in-human clinical trials, they’ll need to reframe their mindset to be GxP-focused, which covers all angles of quality components in a much more streamlined way that enables a company to be successful.

Getting there takes time and effort, but these four planning components can offer guidance.

In order to move towards a GxP QMS, organizations will need to make major shifts in their mindset, adopt quality philosophies and standards, overhaul their quality organizational structure, and unify GxP to move beyond silos to a more integrated system that benefits the organization and their Quality teams.

QMS Unification – A Case Study

In this particular case, the company’s GMP was entirely separate from GCP, GLP, and GPvP, and they believed the separation was essential due to the differences from one GxP component to another.

After observing this company’s structure, all GxPs were placed under one umbrella and all Quality employees reported to the same Quality Leader. As a result, transparency was developed for the entire quality team, silos were eliminated, and processes were streamlined and more efficient. This was valuable to the organization because they used one QMS for their entire GxP which streamlined efficiency and operations for the entire Quality department.

**

From new company formation and early development through commercialization, Halloran is your end-to-end, integrated, full-service partner.

Please contact us to learn more about our Quality Services.