Quality by Design: Concept to Applications

Swain, Sanjit Kumar; Parhi, Rabinarayan; Jena, Bikash Ranjan; Babu, Sitty Manohar

doi:10.2174/1570163815666180308142016

Cited by 28 publications

(15 citation statements)

References 36 publications

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“…16,17 As the 21st century quality scheme by USFDA, the conception of Quality by Design (QbD) has taken gigantic significance in attaining the preferred quality with safer robust product and sound science quality risk management. [18][19][20] This can also be developed by using various sophisticated analytical instruments like (HPLC, UPLC, UFLC) [21][22][23][24][25] and hyphenated techniques (LC-MS, GC-MS, ICP-MS, ICP-OES etc.). [26][27][28][29][30] The reagents and solvents like: IPA.…”

Section: Applications Of CV In Analytical Research and Developmentmentioning

confidence: 99%

Cleaning validation in analytical development: Current challenges and future prospectives

Jena¹,

Swain²,

Pradhan³

et al. 2020

IJPCA

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Cleaning validation is a prominent and ideal practice which is employed in industrial aspects to provide utmost shielding to develop drug products, so that a cleaning practice removes the particulate matters, chemicals, as well as the contaminant pathogens reside in active ingredients of drug product in a piece of apparatus, which are produced or being manufactured. The cleaning validation is established as the pre-eminent process that ensures the efficiency, safety, consistency of pharmaceutical equipment and manufactured product of assured quality. The utmost cleaning practice during manufacturing of drug substances affords the appropriate operator safety measures, organized calibration, description and routine monitoring of equipments, Sampling procedures, acceptance criteria's and detection limits of analytical methods. This also lead to systematic data analysis for estimating of probable contagions in product batches builds up. Abortive cleaning may lead to adulterated product that may be originated from preceding batches, clean-up agents or other superfluous materials produced during methodology. Hence to avoid the harmful contamination, sources, safety measures clean-in-practice is highly recommended as per regulatory and stability point of view. The present review intensifies the current challenges, basic mechanisms and future implication of cleaning validation in various analytical development firms and research organizations.

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Section: Applications Of CV In Analytical Research and Developmentmentioning

confidence: 99%

Cleaning validation in analytical development: Current challenges and future prospectives

Jena¹,

Swain²,

Pradhan³

et al. 2020

IJPCA

Self Cite

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“…Design space incorporates a pre-defined confidence interval for every parameter associated with product quality in the design. Within these combinations of confidence intervals, the quality of the product is assured ( Mishra et al, 2018 , Swain et al, 2019 ). These models can fully rely on historical data or prior experience.…”

Section: Introductionmentioning

confidence: 99%

Industrial application of QbD and NIR chemometric models in quality improvement of immediate release tablets

Ramadan

Basalious

Abdallah

2021

Saudi Pharmaceutical Journal

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Quality by Design (QbD) and chemometric models are different sides of the same coin. While QbD models utilize experimentally designed settings for optimization of some quality attributes, these settings can also be utilized for chemometric prediction of the same attributes. We aimed to synchronize optimization of comparative dissolution results of carvedilol immediate release tablets with chemometric prediction of dissolution profile and content uniformity of the product. As an industrial application, selection of variables for optimization was done by performing risk assessment utilizing the archived product records at the pharmaceutical site. Experimental tablets were produced with 20 different settings with the variables being contents of sucrose, sodium starch glycolate, lactose monohydrate, and avicel Ph 101. Contents of the excipients were modelled with F1 dissimilarity factor and F2 similarity factor in HCL, acetate, and USP dissolution media to determine the design space. We initiatively utilized Partial Least Square based Structural Equation Modelling (PLS-SEM) to explore how the excipients and their NIR records explained dissolution of the product. Finally, the optimized formula was utilized with varied content of carvedilol for chemometric prediction of the content uniformity.

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“…Combined with a deep set of lineage-informative transcript level measurements a better understanding of the cell culture behavior is obtained within the design space ( Mercier et al., 2013 ). Such an approach is integral to a Quality-by-Design (QbD) process ( Juran, 1993 ; McConnell et al., 2010 ; Swain et al., 2018 ). It provides process understanding, allowing for consistent product manufacturing ( Kumar et al., 2014 ; Lipsitz et al., 2016 ).…”

Section: Introductionmentioning

confidence: 99%

“…This systematic approach minimizes the number of experimental runs needed to interrogate multiple parameters simultaneously within a single experimental design (Rathore et al, 2014 (Mercier et al, 2013). Such an approach is integral to a Qualityby-Design (QbD) process (Juran, 1993;McConnell et al, 2010;Swain et al, 2018). It provides process understanding, allowing for consistent product manufacturing (Kumar et al, 2014;Lipsitz et al, 2016).…”

Section: Introductionmentioning

confidence: 99%

High-Dimensional Design-Of-Experiments Extracts Small-Molecule-Only Induction Conditions for Dorsal Pancreatic Endoderm from Pluripotency

et al. 2020

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Summary The derivation of endoderm and descendant organs, such as pancreas, liver, and intestine, impacts disease modeling and regenerative medicine. Use of TGF-β signaling agonism is a common method for induction of definitive endoderm from pluripotency. By using a data-driven, High-Dimensional Design of Experiments (HD-DoE)-based methodology to address multifactorial problems in directed differentiation, we found instead that optimal conditions demanded BMP antagonism and retinoid input leading to induction of dorsal foregut endoderm (DFE). We demonstrate that pancreatic identity can be rapidly, and robustly, induced from DFE and that such cells are of dorsal pancreatic identity. The DFE population was highly competent to differentiate into both stomach organoids and pancreatic tissue types and able to generate fetal-type β cells through two subsequent differentiation steps using only small molecules. This alternative, rapid, and low-cost basis for generating pancreatic insulin-producing cells may have impact for the development of cell-based therapies for diabetes.

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Quality by Design: Concept to Applications

Abstract: This article provides a complete data as well as the road map for universal implementation and application of QbD for pharmaceutical products.

Cited by 28 publications

References 36 publications

Cleaning validation in analytical development: Current challenges and future prospectives

Cleaning validation in analytical development: Current challenges and future prospectives

Industrial application of QbD and NIR chemometric models in quality improvement of immediate release tablets

High-Dimensional Design-Of-Experiments Extracts Small-Molecule-Only Induction Conditions for Dorsal Pancreatic Endoderm from Pluripotency

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