This is part one of a three-part series that explores quality agreements, regulations, guidelines, and working with vendors to ensure quality expectations are met. Part one discusses identifying key risks in partnering with contract companies and working with vendors.

The revolution in scientific knowledge that is bringing hope to patients with devastating diseases is also setting the stage for modernizing our approach to specifications and process control. Updating our approach to specification setting will accelerate the delivery of breakthroughs to patients.

It’s not simply an issue of supply and demand. It’s closer to life and death. Put bluntly, we may not be able to keep up with future clinical trial demand because our workforce isn’t growing fast enough. In fact, by some metrics, we’re already falling behind.

It is important for life sciences companies to understand the regulations laid out in the U.S. Department of Transportation’s 49 CFR Parts 100-185 — and their impact on package design and testing requirements, training requirements, and packaging and handling hazardous materials in bulk and non-bulk forms.

With restrictions on logistics, and countries implementing new restrictions to address increasing COVID-19 cases, it’s important to understand how to manage clinical trials’ ancillary supplies — like sourcing from the right suppliers, managing distribution to all trial sites, stock management, and response to new regulations.

This article is the second in a two-part series about demonstrating CGMP compliance during inspections by establishing a successful quality culture and related systems. Part 1 discussed the importance of “top-down” quality management and “bottom-up” communication of compliance risks and concerns. Here in Part 2, we turn our attention to the input data for an effective QMR.