PAT-based batch statistical process control of a manufacturing process for a pharmaceutical ointment

Bostijn, N.; Dhondt, W.; Vervaet, Chris; Beer, Thomas De

doi:10.1016/j.ejps.2019.05.024

Cited by 11 publications

(8 citation statements)

References 19 publications

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“…Similar to other spectroscopy methods, Raman spectroscopy is commonly used as a real-time monitoring tool for CPV in various pharmaceutical unit processes, including blending, granulation, coating, and tableting. It can analyze the IQAs and CQAs of drug content [ 160 , 161 , 162 ] during the blending process, moisture content [ 8 , 9 ] during the drying and granulation process, and coating thickness and content [ 157 , 163 , 164 ] during the coating process, as well as enable polymorph identification in API preparation [ 165 , 166 , 167 ], granule-formulation analysis [ 8 ], blending uniformity [ 27 , 168 ], particle-size analysis [ 16 , 159 , 169 ], and others.…”

Section: Pat Tools For the Pharmaceutical Manufacturing Processmentioning

confidence: 99%

Process Analytical Technology Tools for Monitoring Pharmaceutical Unit Operations: A Control Strategy for Continuous Process Verification

Kim

et al. 2021

Pharmaceutics

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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.

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Section: Pat Tools For the Pharmaceutical Manufacturing Processmentioning

confidence: 99%

Process Analytical Technology Tools for Monitoring Pharmaceutical Unit Operations: A Control Strategy for Continuous Process Verification

Kim

et al. 2021

Pharmaceutics

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“…On the other hand, studies that combine uni- and multivariate data are scarce. Bostijn et al used MLDF to combine Raman spectroscopic data with univariate variables to monitor the manufacturing of an ointment type product and to reach an enhanced process control [ 156 ]. Probably, the challenges, with respect to the integration of multi- and univariate data into process control models, have limited the combined use of spectroscopic and classical process variables for the real-time monitoring of process evolution.…”

Section: Integrating Df Into Patmentioning

confidence: 99%

Challenges and Opportunities of Implementing Data Fusion in Process Analytical Technology—A Review

et al. 2022

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The release of the FDA’s guidance on Process Analytical Technology has motivated and supported the pharmaceutical industry to deliver consistent quality medicine by acquiring a deeper understanding of the product performance and process interplay. The technical opportunities to reach this high-level control have considerably evolved since 2004 due to the development of advanced analytical sensors and chemometric tools. However, their transfer to the highly regulated pharmaceutical sector has been limited. To this respect, data fusion strategies have been extensively applied in different sectors, such as food or chemical, to provide a more robust performance of the analytical platforms. This survey evaluates the challenges and opportunities of implementing data fusion within the PAT concept by identifying transfer opportunities from other sectors. Special attention is given to the data types available from pharmaceutical manufacturing and their compatibility with data fusion strategies. Furthermore, the integration into Pharma 4.0 is discussed.

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“…In pharmaceutical development, a quality by design (QbD) approach is essential to identify the particularities of drug substances and excipients for new formulations (50-53). This concept allows risk management in the development of new medicines (54)(55)(56)(57)(58). Raman spectroscopy allows for identifying critical variables and their clinical relevance related to quality and safety for patients (26,50,59,60).…”

Section: Spectroscopy Raman In Pharmaceutical Developmentmentioning

confidence: 99%

Raman Spectroscopy for Quantitative Analysis in the Pharmaceutical Industry

2020

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Raman spectroscopy is a very promising technique increasingly used in the pharmaceutical industry. Due to its development and improved instrumental versatility achieved over recent decades and through the application of chemometric methods, this technique has become highly precise and sensitive for the quantification of drug substances. Thus, it has become fundamental in identifying critical variables and their clinical relevance in the development of new drugs. In process monitoring, it has been used to highlight in-line real-time analysis, and it has been used more commonly since 2004 when the Food and Drug Administration (FDA) launched Process Analytical Technology (PAT), integrated with the concepts of Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century. The present review presents advances in the application of this tool in the development of pharmaceutical products and processes in the last six years.

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PAT-based batch statistical process control of a manufacturing process for a pharmaceutical ointment

Cited by 11 publications

References 19 publications

Process Analytical Technology Tools for Monitoring Pharmaceutical Unit Operations: A Control Strategy for Continuous Process Verification

Process Analytical Technology Tools for Monitoring Pharmaceutical Unit Operations: A Control Strategy for Continuous Process Verification

Challenges and Opportunities of Implementing Data Fusion in Process Analytical Technology—A Review

Raman Spectroscopy for Quantitative Analysis in the Pharmaceutical Industry

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