Pharmacopoeial Quality Requirements for Medicinal Products

Olefir, Yu. V.; Sakanyan, E. I.; Шишова, Л. И.; Сенченко, С. П.

doi:10.1007/s11094-019-01929-w

Cited by 7 publications

(2 citation statements)

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“…Modern pharmaceutical manufacture has put forward higher quality requirements for product engineering, which needs to increase the yield and purity as much as possible, ensuring the consistency of crystal products in terms of particle size, crystal shape, crystal type, and chirality, and avoiding particle agglomeration and solvent entrapment [90,91]. However, crystallization process parameters may have a significant impact on the quality attributes of crystalline products, such as purity, morphology, size, polymorphs, impurity, dissolution rate, etc.…”

Section: Applications Of Feedback Control In Crystallizationmentioning

confidence: 99%

Application of PAT-Based Feedback Control Approaches in Pharmaceutical Crystallization

Gao

Zhang

et al. 2021

Crystals

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Crystallization is one of the important unit operations for the separation and purification of solid products in the chemical, pharmaceutical, and pesticide industries, especially for realizing high-end, high-value solid products. The precise control of the solution crystallization process determines the polymorph, crystal shape, size, and size distribution of the crystal product, which is of great significance to improve product quality and production efficiency. In order to develop the crystallization process in a scientific method that is based on process parameters and data, process analysis technology (PAT) has become an important enabling platform. In this paper, we review the development of PAT in the field of crystallization in recent years. Based on the current research status of drug crystallization process control, the monitoring methods and control strategies of feedback control in the crystallization process were systematically summarized. The focus is on the application of model-free feedback control strategies based on the solution and solid information collected by various online monitoring equipment in product engineering, including improving particle size distribution, achieving polymorphic control, and improving purity. In this paper, the challenges of feedback control strategy in the crystallization process are also discussed, and the development trend of the feedback control strategy has been prospected.

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Section: Applications Of Feedback Control In Crystallizationmentioning

confidence: 99%

Application of PAT-Based Feedback Control Approaches in Pharmaceutical Crystallization

Gao

Zhang

et al. 2021

Crystals

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“…Unfortunately, substandard drugs have become a major public health issue worldwide [2][3][4]. According to WHO's Global Surveillance and Monitoring System (GSMS), substandard and falsified medicinal products have been discovered in many countries (Fig 1).…”

Section: Introductionmentioning

confidence: 99%

Key person ethical decision-making and substandard drugs rejection intentions

2020

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Substandard drugs are a major public health issue worldwide. Key person such as the Qualified Person in China and Europe is responsible for rejecting substandard drugs during the manufacturing stage. This study applies the Hunt-Vitell ethical decision-making model to study their rejection intentions on substandard drugs. Using the experimental vignette methodology, two scenarios were developed to represent different levels of deviation from regulations in pharmaceutical manufacturing. Responses from 204 Chinese key persons show a decline in deontology, ethical judgment, and rejection intention, and an increase in teleology in the minor deviation scenario, in comparison with the major deviation scenario. The results from the two scenarios show that the Hunt-Vitell ethical decision-making model is well fitted to explain substandard drug rejection intentions. Organizational and occupational commitments have a significant positive impact on deontological evaluation. Whereas, occupational commitments have a significant negative impact on teleological evaluation. This study suggests that strengthening occupational commitment can significantly affect key person's rejection intentions of substandard drugs.

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