FDA CFR Part 4 compliance
for combination products
The rapid development of combination products—biologics, pharmaceuticals and their devices—provides great opportunity for technological advancement, opening new doors for patient health and improved compliance with administration requirements. The complexity of these systems often requires the device to be developed alongside the drug that it will contain. Whether wearables, injectables or transdermal delivery systems, concerns of maintaining a firm grip on quality and stability throughout the design, manufacturing and product lifecycle process means understanding the GMP requirements of each component. Both are critical to product and compliance success.