Process Validation (IQ/OQ/PQ)

Process validation is an important element of the design transfer process, whether in the context of a new product introduction or relocation of manufacturing to a new plant. It is also an area of regulatory concern, with process validation being the most common manufacturing issue cited during FDA inspectional audits.

Process validation in the regulated medical device environment is still evolving. The FDA is working with the Global Harmonization Task Force to further refine process validation concepts and terminology.

AlvaMed experienced engineers keep up-to-date in the field of process validation and are ready to assist you with your process validation issues in a number of ways. Whether you need to establish a Master Validation Plan for your facility, a Validation Master Plan for a new product introduction, or just need to understand the difference between the two, we can help. If you have an issue with the Installation Qualification (IQ), Operational Qualification (OQ), or Performance Qualification (PQ) of a particular process or need to generate DOE, IQ, OQ, and PQ protocols and reports for an entire product line, we can provide one engineer or an entire team of experts to quickly and effectively validate your processes.

We invite you to review a case study that is representative of the work done by our consultants...

Home | About Us | Services | Team | Clients | Results | Contact Us