Process Validation Is Not the Place to Cut Corners, Experts Advise

Reducing costs in tough economic times is tempting, but drug and device manufacturers should not cut corners when it comes to process validation — especially after release of the FDA’s final process validation guidance, experts advise.

Companies are more willing to spend money on quality processes when they are performing well but may sacrifice quality to decrease costs when profit growth is slow.

And during process validation inspections, the FDA may give companies a false sense of security because inspections are based largely on what investigators observed in previous audits.

But this can come back to bite manufacturers. Device giant Beckman Coulter received a Form 483 last summer with observations on  process validation and device design validation. And Integra subsidiary Theken Spine just got one for not fully validating its process for cleaning returned spinal implant kits.

If you haven’t started revalidating your processes and using your change control SOPs, you’re headed for 483s, warning letters or even recalls that could cost millions of dollars. Make these changes now with help from a new FDAnews webinar — Develop a Process Validation Roadmap.

Last year’s process validation guidance is both daunting and difficult and most companies aren’t really sure how to comply. Many don’t even want to apply the guidance to avoid having to revalidate their processes.

Now that the FDA has significantly changed its approach to process validation, you risk costly enforcement if you haven’t aligned your change controls, monitoring and trending efforts. Develop a Process Validation Roadmap is a webinar that helps you do it all with an easy-to-follow roadmap that has already helped companies with complex processes achieve compliance. Just 90 minutes of your time may save your company millions. Space is limited, so reserve  a line for you and your team now.