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.
Highlights
Methodology ArticleEmail address: To cite this article: Zhu Fugen
The control chart theory has been proposed for decades
In order to timely determine whether the intermediate can flow into the process or not, some parameters need to analysis periodically to keep the process in stable state, such as the moisture of intermediate of solid dosage preparation, weight variation of granules or capsules, Oxygen residue in the top air portion of large volume parenteral solutions (LVP) containers, etc
Summary
Email address: To cite this article: Zhu Fugen. Application of Shewhart Control Charts in the Inspection of Pharmaceutical Manufacturing Process. Received: January 1, 2019; Accepted: January 31, 2019; Published: February 22, 2019
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