Application Note

Application Note: Estimating Return On Investment With Portable Raw Material Identification

Source: Thermo Scientific (formerly Ahura Scientific and Polychromix)

By Dan Klevisha, Polychromix

Identification of raw materials is commonly performed in many industries to ensure that the raw material feed stocks that are being put into the manufacturing process are of the correct type and quality. The pharmaceutical industry goes to great measures to control all aspects of quality, including the rigorous testing of raw materials. Pharmaceutical manufacturers are required to perform identification tests on an on-going basis to ensure product quality and safety.

Over the last few years there have been multiple, well documented problems with substandard and adulterated raw materials which have entered both the non-pharmaceutical and pharmaceutical manufacturing sectors. These significant problems underscore the critical need for effective raw material identification to protect public safety. Quality systems like ISO 9000 and Six Sigma, as well as government quality initiatives such as GMP for the 21st Century, Process Analytical Technology, and ICHQ8 QbD initiatives are increasing the need for more real time quality testing and control procedures. At the same time, pharmaceutical manufacturers are facing pressures to reduce the price of pharmaceutical products and to manufacture more cost effectively.