Introduction
The pharmaceutical industry is unique with its extensive regulations. Decisions concerning quality assurance are usually made on the basis of regulatory requirements and guidelines. Quality control takes a central role in the pharmaceutical industry. In addition to being robust and reliable, the means of quality control therefore must be maximally efficient. Timesaving secondary methods have therefore come into the focus of both the pharmeceutical industry and regulatory authorities.
Near-infrared spectroscopy (NIRS) is a secondary analytical method that has been explored and used in the pharmaceutical industry since early 1960 [1], e.g., for raw material identification, process control, and quality assurance of final products. This analysis technique is very fast, non-destructive, and requires little to no sample preparation. Meanwhile, it acquires information on both chemical and physical sample properties in each measurement. From the data acquired in a single measurement, multiple parameters can be determined – qualitatively or quantitatively. Because of its short measuring times and the non-destructive nature of its measurements, the full potential of NIRS unfolds, in particular, in process control [2]. NIRS is positioned as «a highly relevant tool for achieving control when built-in quality is preferred over quality by testing» by the U.S. Food and Drug Administration (FDA), the Process Analytical Technologies (PAT) initiative, guidelines by the European Medicines Agency (EMA), and the International Conference on Harmonization in the standards (ICH) Q8(R2), ICH Q9 and ICH Q10 [1].
NIRS applications
NIRS is a versatile analysis method and can be used for a vast number of applications throughout the pharmaceutical manufacturing process. In the following, some example applications will be explored with respect to their benefits for production and their compliance with regulations. Incoming materials inspection According to FDA CFR 211.84 and EU GMP 8, all incoming materials have to be tested for verification of the identity and for conformity, thus resulting in a large amount of samples. The Metrohm spectrometer product portfolio offers suitable solutions for a convenient inspection of incoming materials whether they are analyzed directly in the warehouse, in the weighting area or in the QC lab [3, 4]. Inline/online process control Inline/online process control allows less out of specification products manufactured and less rework time to be spent. With Metrohm NIRS inline/online analyzers, real-time monitoring and optimization of, e.g., viable cell density or drying processes can be achieved. Residual solvent and water content in powders and granulates, such as in lyophilized products, can be determined reliably during the production process [3, 5–7].
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