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.

© 2014 IM Publications LLP

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