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.
This is a very interesting factor to point out. Validation deals more with the process of ensuring that the customer’s needs are met. Verification focuses on making sure that the parts involved in creating the product are correct. The validation process is more intense and requires more moneywise and regarding time. The verification process, however, focuses more on the steps to finalizing the product. Based on both processes, the validation process seems to be of more importance and value. The validation process requires more and slows the process especially depending on the company’s policies. The validation method will guarantee that the product is made and follows what is expected by customers.
Actually, the FDA reviews the validation of the manufacturing processes. According to 21 CFR 820.75, which states that "where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated". The validation for manufacturing processes should be documented according to the respective procedures established.
Some companies don’t do a lot of validating because they don’t have the resources or even the necessary understanding. Validation process cost a lot, but validation always required if your company making a new device.(its not a choice).SO Validation process is the right thing to do, because if your product failed to deliver the user needs, it can cause devastating personal consequences, even death. So, validation helps minimize the risks and ensure you’re manufacturing devices according to the user needs.
Validation is required for a new fixture within the company I work for, its not a yes or no question. When dealing with class III medical devices, we rely on validation for new fixtures and processes. Verification are stated in procedures as 100% inspection to verify that the device is being built according to our specifications. Validation are more time consuming and costly but is required to comply with the FDA standards and company standards we uphold to give our customers a safe medical device. Currently, Im working on validating an automated fixture for the production floor and it will require a complete IQ, OQ, PQ , preventative maintenance etc. The cost to have the fixture calibrated, along with getting lots for testing will be cost thousands of dollars. But the safety and reliability that we provide to our customers with a class III medical device requires that we spend that money to validate the fixture.
As @merzkrashed mentions the FDA "results of a process cannot be FULLY verified by subsequent inspection and test" and ISO "processes for production and service provision where the resulting output cannot be verified by subsequent monitory or measurement". So if you can't verify every requirement or verify every single item produced, process validation is needed. As you mentioned, prospective validation can be expensive and FDA has 3 phases; Installation Qualification (IQ), Process Performance qualification, and Product Performance Qualification. I think medical devices, especially class III, would require validation. Although it may be costly to do, in the long run it will end up being beneficial to the company because you end up paying more if these requirements aren't met.
