WHAT IS PROCESS VALIDATION?
The term process validation is not defined in the Food, Drug, and Cosmetic Act (FD&C) Act or in FDA’s CGMP regulations. Many definitions have been offered that in general express the same idea—that a process will do what it purports to do, or that the process works and the proof is documented. A June 1978 FDA compliance program on drug process inspections [2] contained the following definition: This chapter was written by John M. Dietrick in his private capacity. No official support or endorsement by the Food and Drug Administration is intended or should be inferred. A validated manufacturing process is one which has been proved to do what it purports or is represented to do. The proof of validation is obtained through the collection and evaluation of data, preferably, beginning from the process development phase and continuing through the production phase. Validation necessarily includes process qualification (the qualification of materials, equipment, systems, buildings, personnel),
