When you buy a new car you don’t expect it to run smoothly forever. Likewise, despite your diligence and best efforts, glitches will occur and process refinements will be made. Even new or modified processes falter after implementation. Thus, it’s important to remember that process validation is never complete for long. Process performance must be monitored and maintained over time to ensure consistent performance and full or partial revalidation of IQ, OQ, and PQ is simply part of the ongoing cycle. Revalidation requirements should always be considered an integral aspect of an original validation approval.…

The goal is process validation is to produce a stable medical device manufacturing process that offers consistent performance. Variation is minimal and predictable. Your Process Validation Plan (PVP) will provide the framework for executing three important phases in the validation process.

Installation Qualification (IQ): Is everything installed correctly?

Operational Qualification (OQ): Is everything operating correctly? Are operating limits understood?

Performance Qualification (PQ): Did it produce the correct result? Is the process stable and capable?

There are many ways to conduct process validation but given the huge variation in production volumes and manufacturing complexity, you won’t find many suggestions on how to go about it in FDA regulations or in ISO 13485. That being said, this guidance document from 2004 is still the “go to” source for medical device process validation.…

Before introducing a new medical device onto the market, manufacturers should have a high degree of certainty that their manufacturing processes have the proper controls in place to produce products that are safe and meet specified user, technical, and regulatory requirements.

The US FDA and ISO 13485 require device makers to verify that their products meet documented design specifications, and this may be accomplished through post-production inspection or testing. This is otherwise known as “verifying” product quality and, if you choose this route, you’ll need to test every single device you produce.…