Abstract
Various frameworks and methods, such as quality by design (QbD), real time release test (RTRT), and continuous process verification (CPV), have been introduced to improve drug product quality in the pharmaceutical industry. The methods recognize that an appropriate combination of process controls and predefined material attributes and intermediate quality attributes (IQAs) during processing may provide greater assurance of product quality than end-product testing. The efficient analysis method to monitor the relationship between process and quality should be used. Process analytical technology (PAT) was introduced to analyze IQAs during the process of establishing regulatory specifications and facilitating continuous manufacturing improvement. Although PAT was introduced in the pharmaceutical industry in the early 21st century, new PAT tools have been introduced during the last 20 years. In this review, we present the recent pharmaceutical PAT tools and their application in pharmaceutical unit operations. Based on unit operations, the significant IQAs monitored by PAT are presented to establish a control strategy for CPV and real time release testing (RTRT). In addition, the equipment type used in unit operation, PAT tools, multivariate statistical tools, and mathematical preprocessing are introduced, along with relevant literature. This review suggests that various PAT tools are rapidly advancing, and various IQAs are efficiently and precisely monitored in the pharmaceutical industry. Therefore, PAT could be a fundamental tool for the present QbD and CPV to improve drug product quality.
Highlights
Quality control in the pharmaceutical industry has traditionally depended on statistical process control (SPC) [1,2,3,4], which is used to understand the process and desired specification limits and to ensure a stable process by eliminating the allocable sources of variation
As the importance of pharmaceutical quality has increased, various strategies and methods have been introduced, such as continuous process verification (CPV), quality by design (QbD), and real time release test (RTRT), for high-quality pharmaceuticals produced by continuous manufacturing
The QbD approach identifies the correlations between intermediate quality attributes (IQAs), critical process parameters (CPPs), and critical-quality attributes (CQAs) during the process and manages them appropriately during the process
Summary
Quality control in the pharmaceutical industry has traditionally depended on statistical process control (SPC) [1,2,3,4], which is used to understand the process and desired specification limits and to ensure a stable process by eliminating the allocable sources of variation. The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) discussed the need for FDA guidance to facilitate PAT implementation, and the FDA published the PAT guidance for innovative pharmaceutical manufacturing and quality in September 2004 [10] It is recognized as an important paradigm shift in inspecting and approving processes for the continuous process verification of pharmaceutical production processes. This review focuses on applying PAT to QbD, RTRT, and CPV to improve drug quality in the pharmaceutical industry It presents a significant relationship between the process and IQAs with the relevant literature, which could be monitored with PAT framework for. IQAs measured by PAT, equipment type, PAT tools, multivariate statistical tools, and mathematical preprocessing are listed along with relevant literature
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