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Whitepaper: Near-infrared spectroscopy in compliance with pharma regulations
1 March 2017 • Author(s): Metrohm
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 pharmaceutical 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, 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. 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.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Butterworth Laboratories Ltd CAPSUGEL NV Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) Eurofins BioPharma Product Testing EUROGENTEC F.P.S. Food and Pharma Systems Srl GE Analytical Instruments IDBS JEOL Europe Kaiser Optical Systems Inc. L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Lonza MA Business Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Ocean Optics Panasonic Biomedical Sales Europe B.V. Peak Scientific ReAgent Russell Finex Limited Sentronic GmbH Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Viavi Solutions, Inc Watson-Marlow Fluid Technology Group Wickham Laboratories Limited WITec GmbH Xylem Analytics YMC Europe GmbH Yusen Logistics