The FDA defines process
validation as follows:

" Process validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics."

Process validation is a requirement of the Current Good Manufacturing Practices Regulations for Finished Pharmaceuticals, 21 CFR Parts 210 and 211, and of the Good Manufacturing Practice Regulations for Medical Devices, 21 CFR Part 820, and therefore, is applicable to the manufacture of pharmaceuticals and medical devices. Process validation begins at The Electrolizing Corporation of Ohio with a clear understanding of our customers' needs coupled with our Quality Policy, ISO standards and Current Good Manufacturing Practices. During the review process of purchase orders and contracts, our management team develops a validation strategy and a Failure Modes and Effects Analysis that incorporates qualified machinery and trained personnel using the most repeatable and reliable test methods. Process development continues with the manufacturing of “pre-qualification” product. This helps us understand and define the parameters that may affect the outcome of a particular process, such as machining, finishing, assembly and/or packaging process. Our engineering staff may develop multiple Designs of Experiments to further define the ranges of settings for process parameters that may not be fixed. The process will then be qualified by running product at the extremes of these variables, indicating that all products manufactured within the boundaries of these variables produces predictable results. Multiple lots of product are then manufactured and documented at the nominal settings of these parameters, which completes the validation activities.