Competition in the pharmaceutical industry is driving drug companies to spread their manufacturing operations around the globe. Production delocalization results in more testing of the incoming raw materials for quality assurance, product safety and regulatory purposes, which unfortunately results in an increased cost of doing business. This pressure in the production chain from outsourcing is forcing some companies to over-analyze the incoming materials using traditional laboratory testing techniques laid down by the major regulatory organizations like the United States, European and Japanese Pharmacopoeias. The inherent problem with this approach is that it is not sustainable in the long term because of the higher costs, increased manpower and additional resources required.
This demand is straining the analytical capabilities of many companies and introducing unacceptable production over-costs at the manufacturing facilities. In addition, the industry is moving away from a representative sampling approach to a total traceability of the incoming materials. Factors such as continuous changes in manufacturing locations, samples coming from all over the world, and many companies emerging or consolidating their resources all contribute to product quality. Under this scenario, it is easy to understand why regulators require tighter control of the safety and quality of all materials in a pharmaceutical company’s production chain. This application note discusses the economic costs and benefits of the implementation of handheld Raman in the warehouse.
This article was recently published in Volume 12 Issue 1 of Pharmaceutical Manufacturing under the title “Portable Raman for Raw Material QC: What’s the ROI?” Click here to read the full article: http://www.pharmamanufacturing.com/articles/2013/006.html
Additionally, a more detailed application note was created based off of this article which can be found here.