Strategic framework for education and training in Quality by Design (QbD) and process analytical technology (PAT)

Matas, Marcel de; Beer, Thomas De; Folestad, Staffan; Ketolainen, Jarkko; Lindén, Hans H.; Lopes, João A.; Oostra, W.; Weimer, Marco; Öhrngren, Per; Rantanen, Jukka

doi:10.1016/j.ejps.2016.04.024

Cited by 15 publications

(6 citation statements)

References 4 publications

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“…Additionally, one key challenge in the implementation of manufacturing innovation is related to education of pharmacist: the pharmaceutical curriculum is covering broadly several disciplines ranging from chemistry and biology towards social sciences, but is not having enough elements of mathematics and engineering. 31 We envision small scale processing equipment, such as the continuous powder mixing geometry reported here, being an ideal solution for introducing the basic principles of complex engineering aspects. This type of teaching approach would allow for hands-on introduction to continuous manufacturing, process measurements and mathematics related to complex concepts, such as the residence time distribution.…”

Section: Resultsmentioning

confidence: 99%

Rapid Prototyping of Miniaturized Powder Mixing Geometries

Svane

Pedersen²,

Hirschberg³

et al. 2021

Journal of Pharmaceutical Sciences

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Section: Resultsmentioning

confidence: 99%

Rapid Prototyping of Miniaturized Powder Mixing Geometries

Svane

Pedersen²,

Hirschberg³

et al. 2021

Journal of Pharmaceutical Sciences

Self Cite

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“…QbD is a comprehensive approach targeting all phases of drug discovery, manufacturing, and delivery [42,43,44]. QbD consists of many elements, such as quality target product profile (QTPP), critical quality attributes (CQAs), critical process parameters (CPPs), risk assessment, design space, control strategy, product lifecycle management, and continual improvement.…”

Section: Discussionmentioning

confidence: 99%

Improved Understanding of the High Shear Wet Granulation Process under the Paradigm of Quality by Design Using Salvia miltiorrhiza Granules

et al. 2019

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Background: High shear wet granulation (HSWG) is a shaping process for granulation that has been enhanced for application in the pharmaceutical industry. However, study of HSWG is complex and challenging due to the relatively poor understanding of HSWG, especially for sticky powder-like herbal extracts. Aim: In this study, we used Salvia miltiorrhiza granules to investigate the HSWG process across different scales using quality by design (QbD) approaches. Methods: A Plackett–Burman experimental design was used to screen nine granulation factors in the HSWG process. Moreover, a quadratic polynomial regression model was established based on a Box–Behnken experimental design to optimize the granulation factors. In addition, the scale-up of HSWG was implemented based on a nucleation regime map approach. Results: According to the Plackett–Burman experimental design, it was found that three granulation factors, including salvia ratio, binder amount, and chopper speed, significantly affected the granule size (D50) of S. miltiorrhiza in HSWG. Furthermore, the results of the Box–Behnken experimental design and validation experiment showed that the model successfully captured the quadratic polynomial relationship between granule size and the two granulation factors of salvia ratio and binder amount. At the same experiment points, granules at all scales had similar size distribution, surface morphology, and flow properties. Conclusions: These results demonstrated that rational design, screening, optimization, and scale-up of HSWG are feasible using QbD approaches. This study provides a better understanding of HSWG process under the paradigm of QbD using S. miltiorrhiza granules.

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“…DOE also reduces the number of experiments to be performed when a large number of factors (inputs) are involved (14). The concept of QbD has been present in various industries since the 1970s but was introduced into the pharmaceutical industry in 2004 through Pharmaceutical cGMPs for the 21st Century initiative (17); it is also reflected in ICH Q8-Q10 guidelines (18)(19)(20). The QbD approach has been adopted as "analytical quality by design" (AQbD) for analytical method development with peripheral alterations in terminologies (21).…”

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confidence: 99%

Development and validation of a UPLC-MS method for determination of atazanavir sulfate by the “analytical quality by design” approach

2019

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A UPLC-MS method for the estimation of atazanavir sulfate was developed using the "analytical quality by design" approach. The critical chromatographic quality attributes identified were retention time, theoretical plates and peak tailing. The critical method parameters established were percent of organic modifier, flow rate and injection volume. Optimization performed using Box-Behnken Design (BBD) established 10 % organic modifier, 0.4 mL min -1 flow rate and 6-µL injection volume as the optimum method conditions. Atazanavir sulfate eluted at 5.19 min without any interference. Method validation followed international guidelines. The method has proven linearity in the range of 10-90 µg mL -1 . Recovery was between 100.2-101.0 % and precision within the accepted limits (RSD 0.2-0.7 %). LOD and LOQ were 2.68 and 8.14 µg mL -1 , resp. Stress testing stability studies showed atazanavir sulfate to degrade under acidic and basic conditions. The suggested technique is simple, rapid and sustainable. It is, therefore, suggested for routine analysis of atazanavir sulfate.

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Strategic framework for education and training in Quality by Design (QbD) and process analytical technology (PAT)

Cited by 15 publications

References 4 publications

Rapid Prototyping of Miniaturized Powder Mixing Geometries

Rapid Prototyping of Miniaturized Powder Mixing Geometries

Improved Understanding of the High Shear Wet Granulation Process under the Paradigm of Quality by Design Using Salvia miltiorrhiza Granules

Development and validation of a UPLC-MS method for determination of atazanavir sulfate by the “analytical quality by design” approach

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