Process Validation Habits You Should Quit Cold Turkey

IQ/OQ/PQ is for the birds. 
So why are you still using it?

It’s that time again. Time to loosen our belts and get ready to eat ourselves into a food coma feasting on hot, delicious gravy-laden turkey. With turkey on the brain, I started wondering about the phrase “going cold turkey” and how it came to mean the act of quitting something (e.g., substance, behavior or habit) suddenly. And more importantly, when we should do it.
As to its origin, there are many theories out there. Some think the phrase evolved from the older idiom “talking turkey,” which means to speak frankly and directly. Others note the similarities between the physical changes a person goes through as part of the withdrawal process that can leave him or her looking clammy, pale and, well, like a cold turkey (minus the stuffing and cranberry sauce). Everyone seems to agree that “quitting cold turkey” is a pretty unpleasant experience. It also tends to have a lower success rate than the slow and steady approach. So why do we do it? Is the cold turkey technique ever a good option (as opposed to the leftover cold turkey sandwich, which is always a good option)?

When it comes to outdated, dangerous process validation (PV) habits—like clinging to the old IQ/OQ/PQ method or neglecting to incorporate risk into your technology transfer process—quality expert Walt Murray thinks so. His advice: “Just do it!”

In a recent Pharmaceutical Processing article, Murray, CEO of ARC Experts and a MasterControl quality and consulting partner, examined why process people (R&D, production, engineering, QC, QA) have been reluctant to embrace the FDA 2011 Process Validation (PV) Guidance. He also looks at the dangers of poor technology transfer and validation processes and provides a framework for updating your processes quickly and painlessly.

This article is related to the 
Data Sheet: MasterControl Transfer OQ
To get the full details, please download your free data sheet.

Article highlights:

  • How the pharmaceutical industry defines technology transfer and why it is such a critical step in the lifecycle of a drug
  • An overview of the FDA’s 3-Stage Process Validation Model and how it aligns process validation activities with the product lifecycle concept and existing guidelines like ICH Q8, ICH Q9 and ICH Q10
  •  How you can use the updated guidance to legitimize minimal testing
  •  How to apply risk, as it relates to technology transfer, using the FDA's PV 2011 framework

Read the full article.  


Lisa Weeks, a marketing communications specialist at MasterControl, writes extensively about technology, the life sciences, and other regulated environments. Her two decades of marketing and advertising experience include work with McNeil Pharmaceuticals, SAP AG, SCA Mölnlycke, Crozer-Keystone Health Systems, and NovaCare Rehabilitation/Select Med. Her work has appeared in numerous industry publications, including Medical Product Manufacturing NEWS (MPMN), Medtech Pulse, Risk Insights, MD+DI, Pharmaceutical Processing, Genetic Engineering & Biotechnology News (GEN) and PharmaTech.