Drug companies can move beyond simply satisfying FDA regulations by meticulously tracking quality elements, Baxter International quality expert Kevin Cloonan said Monday at the PDA/FDA Joint Regulatory Conference in Washington, D.C.
Using the regulations as guidelines — and focusing on their intent, rather than simply checking boxes — Baxter developed a matrix of 27 quality elements, each containing about 40 different criteria, he said.
The company ranks each manufacturing site’s performance on those criteria from level one to five, Cloonan said. This has allowed the company to identify trends, through quarterly self-assessments and annual independent calibrations, across approximately 50 manufacturing sites worldwide. Examples of quality elements include effective and timely CAPAs, validation processes and change controls.
After expanding the program to all of its sites, Baxter saw lower rates of FDA inspections resulting in Form 483s, and a higher percentage of CAPAs filed on time.