The Role of NIR Spectroscopy in the Measurement of Pharmaceutical Manufacture

Traditional pharmaceutical analysis is focused almost exclusively on the end products of manufacturing processes. Samples are taken from drug substance or drug product batches and analyzed in a remote laboratory. The samples typically go through stages of documentation, sample preparation, analysis, data analysis and documentation once more, prior to the reporting of the analytical results. This approach has served the pharmaceutical industry well but adds significantly to the manufacturing cycle time and does little to ensure actively the quality of materials as they are manufactured. The conventional means to demonstrate quality assurance is to increase inspection levels but this approach could be considered, at best, as a post mortem on the manufacturing process. Indeed the very nature of the analysis is unlikely to correlate well with process performance as the sample matrix is destroyed prior to analysis. The pharmaceutical industry makes measurements on products to demonstrate that processes are validated and 'in control'. The corollary of this proposition is that measurements on processes can demonstrate that products are validated and 'in control'. Process based measurements may offer the pharmaceutical industry significant quality and cost improvements.