Advances in Instrumental Technology, Industry Guidance and Data Management Systems Enabling the Widespread Use of near Infrared Spectroscopy in the Pharmaceutical/Biopharmaceutical Sector

Abstract

Smaller, faster and more robust instrumentation combined with improved regulatory and industry guidance and advanced data management systems have all contributed to making the near infrared (NIR) spectroscopy technique a viable alternative to traditional in-process and final-release testing strategies in the pharmaceutical/biopharmaceutical industry. The NIR method cannot be used to replace all testing methods, but when it can be applied, it provides greater insights into the state of a process or product. It also provides real- or near-real-time quality information, allowing process operators, Quality Assurance personnel or Advanced Process Control systems to take a proactive, rather than reactive, approach to quality during the manufacturing process. This review summarises the developments in instrumentation, regulatory/industry guidance and information management systems that better enable the implementation of NIR technology into routine laboratory and process applications. A short review comparing the NIR and Raman techniques is provided, outlining the complementary nature of the two methods along with a discussion on how the two methodologies have experienced a similar evolution over the past 14 years.