Review of the article „The Impact of Analytical Quality by Design (AQbD) in the Method Development of Liquid Chromatography for Quality Control of Pharmaceuticals: A Review“, verified by Publons, Web of Science
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The objective of this review article is to provide a comprehensive understanding on different
steps of AQbD, along with their concern ICH guidelines. The concepts of quality by design are
described in ICH Q8-Q10, which have also been applied to analytical methods. Analytical
quality by design Analytical involves following steps: Analytical target profile (ATP) critical
quality attribute (CQA), critical process parameters (CPP), Risk assessment: (failure mode
effects analysis -FMEA , Ishikawa diagrams-fishbone diagrams), design of experiment (DOE),
ANOVA has been perform to identify the significant and insignificant factors using design
expert software, design space (DS) and control strategy, and PAT. The application of QbD
principles to analytical method development is focused on the concept of building quality into
the method during development, instead of testing methods for quality after development. The
aim of pharmaceutical development (ICH Q8) is to design a quality pro...duct and its
manufacturing process to consistently deliver the intended performance of the product. The
information and knowledge gained from pharmaceutical development studies and manufacturing
experience provide scientific understanding to support the establishment of the design space*,
specifications, and manufacturing controls. The ICH Q 9 guideline provides principles and
example of tools for quality risk management that can be applied to different aspects of
pharmaceutical quality. The objective of ICH Q10 is the implementation of the Q 10 model
should result in achievement of three main objectives which complement or enhance regional
GMP requirement.
Izvor:
Current Pharmaceutical Analysis, 2019, 1/BMS-CPA-2019-15-18Kolekcije
Institucija/grupa
Mašinski fakultetTY - JOUR AU - Jovanović, Tamara PY - 2019 UR - https://machinery.mas.bg.ac.rs/handle/123456789/5945 AB - The objective of this review article is to provide a comprehensive understanding on different steps of AQbD, along with their concern ICH guidelines. The concepts of quality by design are described in ICH Q8-Q10, which have also been applied to analytical methods. Analytical quality by design Analytical involves following steps: Analytical target profile (ATP) critical quality attribute (CQA), critical process parameters (CPP), Risk assessment: (failure mode effects analysis -FMEA , Ishikawa diagrams-fishbone diagrams), design of experiment (DOE), ANOVA has been perform to identify the significant and insignificant factors using design expert software, design space (DS) and control strategy, and PAT. The application of QbD principles to analytical method development is focused on the concept of building quality into the method during development, instead of testing methods for quality after development. The aim of pharmaceutical development (ICH Q8) is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. The information and knowledge gained from pharmaceutical development studies and manufacturing experience provide scientific understanding to support the establishment of the design space*, specifications, and manufacturing controls. The ICH Q 9 guideline provides principles and example of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. The objective of ICH Q10 is the implementation of the Q 10 model should result in achievement of three main objectives which complement or enhance regional GMP requirement. T2 - Current Pharmaceutical Analysis T1 - Review of the article „The Impact of Analytical Quality by Design (AQbD) in the Method Development of Liquid Chromatography for Quality Control of Pharmaceuticals: A Review“, verified by Publons, Web of Science EP - 18 SP - 1/BMS-CPA-2019-15 UR - https://hdl.handle.net/21.15107/rcub_machinery_5945 ER -
@article{ author = "Jovanović, Tamara", year = "2019", abstract = "The objective of this review article is to provide a comprehensive understanding on different steps of AQbD, along with their concern ICH guidelines. The concepts of quality by design are described in ICH Q8-Q10, which have also been applied to analytical methods. Analytical quality by design Analytical involves following steps: Analytical target profile (ATP) critical quality attribute (CQA), critical process parameters (CPP), Risk assessment: (failure mode effects analysis -FMEA , Ishikawa diagrams-fishbone diagrams), design of experiment (DOE), ANOVA has been perform to identify the significant and insignificant factors using design expert software, design space (DS) and control strategy, and PAT. The application of QbD principles to analytical method development is focused on the concept of building quality into the method during development, instead of testing methods for quality after development. The aim of pharmaceutical development (ICH Q8) is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. The information and knowledge gained from pharmaceutical development studies and manufacturing experience provide scientific understanding to support the establishment of the design space*, specifications, and manufacturing controls. The ICH Q 9 guideline provides principles and example of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. The objective of ICH Q10 is the implementation of the Q 10 model should result in achievement of three main objectives which complement or enhance regional GMP requirement.", journal = "Current Pharmaceutical Analysis", title = "Review of the article „The Impact of Analytical Quality by Design (AQbD) in the Method Development of Liquid Chromatography for Quality Control of Pharmaceuticals: A Review“, verified by Publons, Web of Science", pages = "18-1/BMS-CPA-2019-15", url = "https://hdl.handle.net/21.15107/rcub_machinery_5945" }
Jovanović, T.. (2019). Review of the article „The Impact of Analytical Quality by Design (AQbD) in the Method Development of Liquid Chromatography for Quality Control of Pharmaceuticals: A Review“, verified by Publons, Web of Science. in Current Pharmaceutical Analysis, 1/BMS-CPA-2019-15-18. https://hdl.handle.net/21.15107/rcub_machinery_5945
Jovanović T. Review of the article „The Impact of Analytical Quality by Design (AQbD) in the Method Development of Liquid Chromatography for Quality Control of Pharmaceuticals: A Review“, verified by Publons, Web of Science. in Current Pharmaceutical Analysis. 2019;:1/BMS-CPA-2019-15-18. https://hdl.handle.net/21.15107/rcub_machinery_5945 .
Jovanović, Tamara, "Review of the article „The Impact of Analytical Quality by Design (AQbD) in the Method Development of Liquid Chromatography for Quality Control of Pharmaceuticals: A Review“, verified by Publons, Web of Science" in Current Pharmaceutical Analysis (2019):1/BMS-CPA-2019-15-18, https://hdl.handle.net/21.15107/rcub_machinery_5945 .