Implementation of Current Good Manufacturing Practices in a small research laboratory setting

Abstract

The Current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals as found in 21 CFR 211 is specifically geared to the regulation of drug-manufacturing processes in industry. However, under some circumstances, it becomes necessary to apply the regulation to manufacturing operations in a research laboratory setting. Application of the regulations in such a setting requires management commitment, cooperation between QA/QC and technical staff, patience, creativity, and an understanding of the spirit behind the letter of the law. Breaking down the regulations into their fundamental parts gives insight into the intent of the regulations and aids in their application. This article will outline our experience in applying the cGMP in a research laboratory setting