Using a cGMP pharmacy at your CRU for Phase I drug manufacturing yields benefits in quality and safety, timeline reduction and cost efficiency.
The regulatory environment continues to move toward requiring drug manufacturing at current good manufacturing practice (cGMP)-compliant pharmacies. This trend and other factors make it increasingly attractive to use cGMP compounding on-site at your CRU for early development. Let’s look at Three Big Benefits for Phase I drug manufacturing:
- Quality and safety
- Timeline reduction
- Cost efficiency
The integrity of any Phase I clinical program relies heavily on the production, supply and analysis of quality dose formulations. Historically, drug doses have been formulated, manufactured and analyzed at the contract manufacturer, which typically adds significant time and expense given the small volume and the regulatory expectations at Phase I. One solution that is becoming widely practiced is combining extemporaneous preparations at the clinical research unit with independent dose analysis. It’s a one-two punch that not only saves time and money, it provides an extra assurance of quality.
Pharmacies are nimble
Contract manufacturers are built for the scale and regulatory requirements of a large Phase III clinical trial. Volume is their game. In Phase I, volume is overkill and leads to additional time and cost. Continue reading