Application of Shewhart Control Charts in the Inspection of Pharmaceutical Manufacturing Process
International Journal of Pharmacy and Chemistry
Volume 5, Issue 1, January 2019, Pages: 1-11
Received: Jan. 1, 2019; Accepted: Jan. 31, 2019; Published: Feb. 22, 2019
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Author
Zhu Fugen, Guangdong P. D. Pharmaceutical Co., Ltd. Kaiping, China
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Abstract
Control charts, also known as Shewhart Control charts, are used to determine if a manufacturing process is in a state of statistical control. This article illustrates the use of charts to evaluate pharmaceutical manufacturing process variability. According to the characteristics and control requirements of quality parameters, several types of typical parameters were introduced to illustrate the detection results and create the control charts in order to confirm whether the production was under control. Expedite the operator discovering the process variation caused by special factors, and taking corrective actions so that the products consistently complied with the regulatory specifications and production instructions.
Keywords
Pharmaceutical Manufacturing, Statistical Control, Shewhart Control Charts
To cite this article
Zhu Fugen, Application of Shewhart Control Charts in the Inspection of Pharmaceutical Manufacturing Process, International Journal of Pharmacy and Chemistry. Vol. 5, No. 1, 2019, pp. 1-11. doi: 10.11648/j.ijpc.20190501.11
Copyright
Copyright © 2019 Authors retain the copyright of this article.
This article is an open access article distributed under the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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