Medtech Tips: Should A Combo Product-Maker's Quality System Be Device- Or Drug-Led? J&J, Eli Lilly Experts Weigh In

23 Jan 2019

• By Shawn M. Schmitt

How manufacturers of drug-device combination products set up their quality system depends on various factors, including the primary mode of action – the constituent part of the product that offers the most overall benefit. So say experts from Johnson & Johnson, Eli Lilly and PAREXEL, who offer other tips and advice.

Tips word collected of wooden elements with the letters

When Anita Michael walks into a facility to help facilitate a US FDA inspection of a combination drug-device product-maker, one of the first things she and agency investigators must determine is whether the firm's quality system is drug- or device-led.

"We would want to know, what is your main system? Do you have a CGMP [Current Good Manufacturing Practice]...