In the lecture for this topic Dr. Simon explained the difference between process validation and process verification. Process validation is definitely the preferred method, as it ensures the process is highly controlled and ultimately results in a more efficient manufacturing process in the long run. I can think of 2 reasons why companies would choose not to validate a manufacturing process. First of all, it is a large up front cost and time investment to validate a process if you do prospective validation, and for a small start up company, this may not fit their business model. The other reason is that larger companies may have very strict procedures for performing process validation, and sometimes they set the bar too high, making it very difficult to pass the process validation. Since they are unable to pass process validation, they resort to verification, such as 100% inspection. This is something that I have seen happen in my company.

I would like to hear everyone else’s perspective on this, and if you have any experience with these scenarios please share.