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.
| Published in | International Journal of Pharmacy and Chemistry (Volume 5, Issue 1) |
| DOI | 10.11648/j.ijpc.20190501.11 |
| Page(s) | 1-11 |
| Creative Commons |
This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited. |
| Copyright |
Copyright © The Author(s), 2024. Published by Science Publishing Group |
Pharmaceutical Manufacturing, Statistical Control, Shewhart Control Charts
| [1] | ISO 7870: 1993, Control charts – General guide and introduction. |
| [2] | ISO 3534-1: 2006 Statistics - Vocabulary and symbols - Part 1: General statistical terms and terms used in probability. |
| [3] | ISO 3534-2: 2006 Statistics - Vocabulary and symbols - Part 2: Applied statistics. |
| [4] | NELSON, L. S., The Shewhart Control Chart-Tests for Special Causes. Journal of Quality Technology, 16, No. 4, October 1984, pp. 237-239. |
| [5] | NELSON, L. S., The Shewhart X Control Chart. Journal of Quality Technology, 17, No. 2, April 1985, pp. 114-116. |
| [6] | Pharmacopoeia of the People’s Republic of China [S]. 2015.Volume Ⅳ. General Requirements for Preparations. |
| [7] | ISO 7870-2:2013 Control chars, Part 2: Shewhart control Charts. |
| [8] | Juran, J. M., ed. (1988). Juran’s Quality Control Handbook, McGraw-Hill, New York. |
| [9] | 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. |
| [10] | Wheeler, Donald J. (2009-05-26), When Can We Trust the Limits on a Process Behavior Chart?, Quality Digest, retrieved 2010-02-08. |
APA Style
Zhu Fugen. (2019). Application of Shewhart Control Charts in the Inspection of Pharmaceutical Manufacturing Process. International Journal of Pharmacy and Chemistry, 5(1), 1-11. https://doi.org/10.11648/j.ijpc.20190501.11
ACS Style
Zhu Fugen. Application of Shewhart Control Charts in the Inspection of Pharmaceutical Manufacturing Process. Int. J. Pharm. Chem. 2019, 5(1), 1-11. doi: 10.11648/j.ijpc.20190501.11
AMA Style
Zhu Fugen. Application of Shewhart Control Charts in the Inspection of Pharmaceutical Manufacturing Process. Int J Pharm Chem. 2019;5(1):1-11. doi: 10.11648/j.ijpc.20190501.11
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Download@article{10.11648/j.ijpc.20190501.11,
author = {Zhu Fugen},
title = {Application of Shewhart Control Charts in the Inspection of Pharmaceutical Manufacturing Process},
journal = {International Journal of Pharmacy and Chemistry},
volume = {5},
number = {1},
pages = {1-11},
doi = {10.11648/j.ijpc.20190501.11},
url = {https://doi.org/10.11648/j.ijpc.20190501.11},
eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijpc.20190501.11},
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.},
year = {2019}
}
TY - JOUR T1 - Application of Shewhart Control Charts in the Inspection of Pharmaceutical Manufacturing Process AU - Zhu Fugen Y1 - 2019/02/22 PY - 2019 N1 - https://doi.org/10.11648/j.ijpc.20190501.11 DO - 10.11648/j.ijpc.20190501.11 T2 - International Journal of Pharmacy and Chemistry JF - International Journal of Pharmacy and Chemistry JO - International Journal of Pharmacy and Chemistry SP - 1 EP - 11 PB - Science Publishing Group SN - 2575-5749 UR - https://doi.org/10.11648/j.ijpc.20190501.11 AB - 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. VL - 5 IS - 1 ER -
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