Next generation quality control in future pharmaceutical processes
Near-infrared (NIR) spectroscopy enables the determination of the amount of active pharmaceutical ingredients (API) and excipients in pharmaceutical production. The quality of pharmaceutical ingredients is absolutely critical in ensuring patient safety. Global pharmaceutical revenues increased to over one trillion US dollars in 2014. A capacity to measure qualityrelated costs has been advocated as an important component of quality improvement with quality related costs ranging
from 10–30 per cent of sales and 25–40 per cent of operating expenses.1
Pharmaceutical production is traditionally carried out in batch processes. The process phases of pharmaceutical production include steps like granulation, blending, tableting, and coating. The quality of raw materials and end-products needs to be checked but also the quality of each of these manufacturing steps.
Nowadays more and more continuous manufacturing concepts are also studied in the pharmaceutical industry. Real-time quality measurements will play an even more important role when continuous manufacturing is used in the future. Quality control should offer operators real-time information on production quality to ensure the quality attributes of the final product. One of the latest trends in the pharmaceutical industry is to aim towards personalized medicines which will mean that pharmaceutical products will be produced in small batches utilizing novel printing technologies.
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