Process validation is not a curse invented by regulators and pushed onto a company by QA staff.  Instead, it is a legal requirement in the pharmaceutical and healthcare industries.  The concept of process validation is recognition that quality cannot be tested into the product and must be designed into the process/product to reduce the risk of non-conformances during/after manufacturing. In some cases, destructive testing is required to show that the manufacturing process is adequate.  In certain situations end-product testing does not reveal variations that may occur in the product which may impact safety and effectiveness. The FDA believes through careful design and validation of both the process and process controls, a manufacturer can establish a high degree of confidence that all manufactured units from successive lots will be acceptable. Successfully validating a process may reduce the dependence upon intensive in-process and finished product testing.