Quality by design (QbD) and process analytical technology (PAT) applications in pharmaceutical industry

Abstract

Quality by Design (QbD) for the pharmaceutical industry includes the design, development and production control of products and production processes from the beginning to the end of the product development phase for ensuring the consistent quality of a pharmaceutical product. The QbD is a systematic scientific approach aimed at meeting the needs of the patient in the desired and targeted quality and aiming to produce the same quality pharmaceutical product in this direction. Process Analytical Technology, which is assessed in that regard, is part of a design quality approach that is used to design, analyze, and control real-time measurements of quality and performance criteria for raw and processed materials to achieve the desired final product. This scientific and systematic approach to pharmaceutical product development, which is also acknowledged and supported by the health authorities, serves to the changing and developing pharmaceutical sector.

Recent Advances in Chromatography for Pharmaceutical Analysis

“…Applying this PAT approach has the ability to save the time and money required for product sampling and analysis and to produce quality and stable products in a shorter period of time. 168 Many of the progresses in continuous manufacturing are closely related to the Food and Drug Administration (FDA) Pharmaceutical Quality for the 21 st Century Initiative, which aims at promoting the modernization of pharmaceutical manufacturing thanks to the implementation of quality by design (QbD) and PAT to enable new manufacturing technologies.…”

“…Thanks to PAT, errors can be corrected while the process is in progress so that material losses can be avoided or strongly reduced during an industrial process. Applying this PAT approach has the ability to save the time and money required for product sampling and analysis and to produce quality and stable products in a shorter period of time …”

“…Therefore, there have been many attempts in the past few years to integrate PAT and continuous manufacturing within pharmaceutical industries . In many cases, spectroscopic-based tools such as ultraviolet–visible (UV–vis), near-infrared (NIR), Fourier transform-infrared (FT-IR), and Raman spectroscopy have been successfully used for real time monitoring and process control, including the monitoring of extraction and crystallization processes, the production of solid dosage forms, and the quantitation of active substances and impurities . However, these approaches often lack specificity and sensitivity for several other PAT applications.…”

“…169 In many cases, spectroscopicbased tools such as ultraviolet−visible (UV−vis), near-infrared (NIR), Fourier transform-infrared (FT-IR), and Raman spectroscopy have been successfully used for real time monitoring and process control, 170 including the monitoring of extraction and crystallization processes, the production of solid dosage forms, and the quantitation of active substances and impurities. 168 However, these approaches often lack specificity and sensitivity for several other PAT applications. For this reason, chromatography might be considered to be a useful strategy considering its excellent robustness, specificity, and resolution.…”

Artificial Intelligence-based Prediction of In Vitro Dissolution Profile of Immediate Release Tablets with Near-infrared and Raman Spectroscopy

“…In-process measurements can be performed using PAT sensors based on near infrared (NIR), Raman, ultraviolet-visible (UV-VIS), Terahertz pulse, light-induced fluorescence, X-ray and laser light scattering signals [16][17][18]. NIR and Raman spectroscopy have become the frequently used real-time monitoring tools in the pharmaceutical industry.…”