Full
Outline
Continuous manufacturing (CM) of solid dosage forms enables materials passing through integrated dispensing system, saving operation time and reducing human errors, thus is developing into a preferred platform for pharmaceutical products. European and American drug regulatory agencies have approved several commercial CM solid dosage form drugs. The role of control strategy for CM is based on scientific framework to identify and to reduce the risk of manufacturing variation. Process analysis technology (PAT) monitoring methods can improve product quality in real time, promote continuous improvement and innovation in manufacturing, and thus achieve advanced process control and real-time release of products. The ultimate goal is to bring safer medicines to the market more quickly and cost-effectively, as well as to achieve the digitalization and process analytics of pharmaceutical 4.0. This review article discussed the modeling and associated risk mitigation, advanced control strategies of PAT in the implementation of CM processes for solid dosage form products, and the potential challenges of regulator's expectations from industrial perspective. The current situation of new drug approvals and related PAT implementations from international pharmaceutical companies were also illustrated and discussed.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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