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
Views 774      Downloads 149
Zhu Fugen, Guangdong P. D. Pharmaceutical Co., Ltd. Kaiping, China
Article Tools
Follow on us
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.
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 © 2019 Authors retain the copyright of this article.
This article is an open access article distributed under the Creative Commons Attribution License ( which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
ISO 7870: 1993, Control charts – General guide and introduction.
ISO 3534-1: 2006 Statistics - Vocabulary and symbols - Part 1: General statistical terms and terms used in probability.
ISO 3534-2: 2006 Statistics - Vocabulary and symbols - Part 2: Applied statistics.
NELSON, L. S., The Shewhart Control Chart-Tests for Special Causes. Journal of Quality Technology, 16, No. 4, October 1984, pp. 237-239.
NELSON, L. S., The Shewhart X Control Chart. Journal of Quality Technology, 17, No. 2, April 1985, pp. 114-116.
Pharmacopoeia of the People’s Republic of China [S]. 2015.Volume Ⅳ. General Requirements for Preparations.
ISO 7870-2:2013 Control chars, Part 2: Shewhart control Charts.
Juran, J. M., ed. (1988). Juran’s Quality Control Handbook, McGraw-Hill, New York.
T. C. Chang, F. F. Gan. Application of X̄ control chart with modified limits in process control. Quality & Reliability Engineering 15 (5). September 1999, pp.355-362.
Wheeler, Donald J. (2009-05-26), When Can We Trust the Limits on a Process Behavior Chart?, Quality Digest, retrieved 2010-02-08.
Science Publishing Group
1 Rockefeller Plaza,
10th and 11th Floors,
New York, NY 10020
Tel: (001)347-983-5186