The Value of Lean Sigma: Improving GC Processes in Pharmaceutical R&D

Gas Chromatography-Flame Ionisation Detection (GC-FID) and Gas Chromatography-Mass Spectrometry (GC-MS) are techniques fundamental to the pharmaceutical R&D industry. These techniques measure the quality of raw materials and intermediates used in the manufacture of active pharmaceutical ingredient (API) and deliver knowledge into the synthetic organic process for effective learning. Raw materials, intermediates and impurities seen in the manufacturing process typically cover a wide range of polarities and are often highly structurally related, (e.g positional isomers). The supporting analytical methods must therefore be highly efficient and selective. 

As a consequence, compound specific methods are typically developed.

Internal data show compound specific methods are struggling to support increased project demand. This article discusses the combination of new lean methodologies with advances in column technologies in order to improve efficiency of the GC process from method development to commercial technology transfer. These improvements have successfully responded to increased project demands in our organisation without requirement for large-scale financial investment.