Good input folks!
In my experience, few smaller contract manufacturers/suppliers have the understanding and the resources to execute an IQ/OQ/PQ. However, I recognize that if one were to have the capability, it would get my attention.
While driving home tonight, I was thinking about something an ex-FDA agent told me. It was his belief that Process Control at a supplier did more for a manufacturer than a Process Validation. Although the requirement is to periodically revisit validation, the reality is that it isn’t often done (except when the process changes significantly). Process Control is real time there for a better solution in his mind. He may have a point. Nonetheless, if the item you’re producing is a final product, Process Validation or Qualification might be mandatory. Look into your options.
As noted above, take a look at what FDA has to say on Process Validation. Also, read the Global Harmonization Task Forces Guidance on the Principles of Process Validation. You should find all you need to understand the concept well enough, however, the combination of good theory and experience (perhaps provided by a hired resource) yields the best results. Because this is generally an expensive process, going cheap usually results in poor results that aren’t worth much. For validations I have been a part of, costs ranged between $40K and $2M+. Recognizing the kind of investments possible, going short on a resource might prove to be a costly error. On a few occasions, costly validations had to be repeated because of poor preparation and inexperience. Luckily I worked with a company with deep pockets. Without that luxury, it is possible to sink a smaller organization.
It looks like you have some capable colleagues to glean information from. This looks like it might be a very productive thread.
Good input everyone!
Kevin