Each process should have specifications describing both the process parameters and the desired product.
The decision tree shown here can be used to identify which processes should be validated.
If the process output is verifiable and the verification is sufficient to assure product quality and is cost effective, then you can verify and control the process.
Conversely if the product is not adequately verifiable or is not cost effective then you need to either validate the process or redesign either the product, the process or both
Process Should be Validated
Based on this the manufacturer can decide whether the output can be verified by monitoring or measurement, or if verification alone is not sufficient, then the process should be validated.
Risk analysis should be used to decide this.
Also, changes in the processes that formerly were only verified may result in the need to validate and would need to be re-evaluated.
21 CFR Part 820.75(a)
21 CFR part 820.75(a) stipulates that if process results cannot be fully verified during routine production by inspection and testing such as, measuring the length or checking the pH, then the process must be validated according to established procedures.
This is especially important to validate a process when routine, end-product, testing will not reveal all variations that may occur in the finished devices.
Process validation is also necessary, if clinical or destructive testing is required to show that the manufacturing process has successfully produced the desired product.
Finally, if the process capability is not known, or if the process is suspected of barely capable of meeting device specifications, a non-robust process would need to be validated.
The new FDA principles of Quality Assurance, which are discussed in the new FDA guidance published in January of 2011, are based on the principle that quality cannot be adequately assured merely by in-process and finished-product inspection or testing and has to be built into the product.
These new principles have been incorporated into this course.