Process Performance as a Means of Quality Management

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Quality by design (QbD) was an initiative introduced by FDA in 2004 to improve pharmaceutical development and manufacturing. QbD leverages quality tools, such as process performance, that estimate performance during initial setup before a process has been brought to a state of statistical control. By using QbD, pharmaceutical development, and hence manufacturing, becomes a more efficient process. To illustrate the utilization of quality management techniques, process performance will be utilized as an example in the simple process of tablet splitting. Principles and findings can be further extrapolated to more complex processes. For the present study, the process performance metrics of eight different mechanical devices were assessed to evaluate the compliance of these devices with regulatory and compendial criteria. These process performance metrics were used to differentiate the mechanical devices based on their degree of compliance with regulatory and compendial requirements and make recommendations based on values of these metrics, thus increasing process knowledge and understanding.

Peer-Reviewed

Submitted: Oct. 13, 2021
Accepted: Dec. 6, 2021

About the author

Ammar Khawam, PhD, is a senior managing scientist of product development at Parsolex.

Article Details

Pharmaceutical Technology
Vol. 46, No. 3
March 2022
Pages: 28–35

Citation

When referring to this article, please cite it as A. Khawam, “Process Performance as a Means of Quality Management,” Pharmaceutical Technology, 46 (3) 28–35 (2022).