Effects of FDA Inspections on Chemical Development

Abstract

The FDA regulations, even though written with the drug product in mind, are applied more and more to the manufacture of drug substances. The FDA would like to see written evidence that the synthetic process is well understood and under control, since a well-developed process assures reproducible quality of the drug substance. It is the responsibility of chemical development to write such a development report which includes process validation. This paper describes a development report with illustrative examples and defines the concept of drug substance process validation. The effects the new FDA guidelines will have on chemical development are a lot more documentation and a little more experimentation in the area of process validation.