APPLICATION OF QUALITY BY DESIGN (QBD) APPROACH TO THE DEVELOPMENT OF A CYTOPHEROMETRIC ANALYTICAL METHOD OF HUMAN RED BLOOD CELLS: COMPARISON WITH TRADITIONAL DEVELOPMENT METHODOLOGY

2020 ◽  
pp. 237-256
Author(s):  
Fernando Ferrandiz Vindel
Keyword(s):  
Analytical Methods ◽  
Quality By Design ◽  
Drug Analysis ◽  
Human Red Blood Cells ◽  
Process Understanding ◽  
Physico Chemical ◽  
Scope Of Application ◽  
Product And Process ◽  
Development And Validation ◽  
And Control

Quality by Design (QbD) is defined as a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management, according to ICH Q section guidelines definition. Although this definition does not specifically mention analytical methods, since 2007 there have been authors who have defended the possibility of applying the principles of QbD to the development and validation of analytical methods in order to ensure their ruggedness and robustness, especially in the field of physical and physicochemical methods related to the quantitative drug analysis. However, in our experience, the real scope of application of QbD for analytical methods can include not only the quantitative analysis of drugs, but also other analytical methods in which other properties are determined, such as cytoferometry, a specific type of cell and particle suspension electrophoresis, with which it is possible to determine the electrophoretic mobility of normal and pathological erythrocytes. Data of the original development of a cytopherometric method carried out in 1988 have been reprocessed according to current QbD principles, and the results obtained with the traditional methodology and with the QbD methodology have been compared. This comparison demonstrates that the results processed following QbD show an enhancement in the knowledge and control of the cytopherometric method, giving more flexibility on physical and physico-chemical parameters management and appropriate tools to control the principal sources of analytical variability.

scholarly journals QBD, REVIEW ON COMPREHENSIVE UNDERSTANDING OF BUILDING AN ANALYTICAL QUALITY BY DESIGN FOR DRUG MANUFACTURING PROCESS

2020 ◽  
Vol 9 (2) ◽  
Author(s):  
Shishir Kumar Prasad ◽  
Kalpana Diwekar ◽  
Anita.A
Keyword(s):  
Risk Management ◽  
Analytical Methods ◽  
Quality By Design ◽  
Spectroscopic Method ◽  
Pharmaceutical Product ◽  
Critical Parameters ◽  
Current Status ◽  
Product Concept ◽  
Knowledge Based ◽  
Product And Process

When knowledge based on pure scientific understanding and quality risk management is applied to product and process learning with regulation on process control along with a systematic approach for development of predefined objectives in analytical field then it is called as quality by design or QBD it follow ICH guidelines for quality in pharmaceutical product concept of qbd also extends to analytical methods, it is mandatory process in QBD to define a goal. A protocol for the method which will continue monitoring the process throughout in a systematic way and working on alternate methods as well to get optimal performance, the methods given are carefully analysed in structured pattern for risks and is put for a challenge of the validity of method which later on can be taken for the criteria, benefit of these studies. The performances can be improved as well as clearly understood along with the risk management and desired performance methods  which can also be validated later on, the review briefly gives an inside view of application of analytical QBD in industries and its current status with examples and principles of analytical methods in HPTLC ,titration for moisture content, determination of   toxic impurities in mixtures,quantative colour measurement and various spectroscopic method for identification of chemical moiety. Qbd developed spectroscopic    and chromatographic method are usually done as per ICH Q8 R2   , the critical parameters are compared to principle observation  and analysis, the HPTLC method employs solvent usage and detection of absorbance and wavelength comparison.

scholarly journals Implementation of Quality by Design for the Development and Validation of Pioglitazone Hydrochloride by RP-UPLC with Application to Formulated Forms

2012 ◽  
Vol 2012 ◽  
pp. 1-11 ◽  
Author(s):  
Cijo M. Xavier ◽  
Kanakapura Basavaiah
Keyword(s):  
Quality By Design ◽  
Pharmaceutical Formulations ◽  
Calibration Graph ◽  
Process Understanding ◽  
Validation Criteria ◽  
Relative Standard ◽  
Level Of Knowledge ◽  
Bulk Drug ◽  
Development And Validation

Quality by Design (QbD) is a philosophy that refines the level of knowledge associated with a product that uses process understanding to deliver a product with the desired critical quality attributes. The objective of this study was to develop an integrated multivariate QbD approach to develop and quantify the constituent concentrations of pioglitazone hydrochloride (PGZ) drug in its pure and formulated forms. To facilitate studies investigating the determination of PGZ in bulk drug and its pharmaceutical formulations, a rapid UPLC method was developed and validated for the determination of PGZ accompanied by its degradation studies in different stress conditions. The method fulfilled validation criteria and was shown to be sensitive, with limits of detection (LOD) and quantitation (LOQ) of 0.01 and 0.05 μg mL−1, respectively. The percent relative standard deviations for robustness and ruggedness were observed within the range of 0.1–1.74. The calibration graph was linear in the range of 0.05–300 μg mL−1. The applicability of the method was shown by analysis of formulated drug samples and spiked human urine. The proposed method can be used for routine analysis in quality controlled laboratories for its bulk and formulated product and this is the first reported UPLC method for the assay of PGZ.

scholarly journals Perspectives in modeling and model validation during analytical quality by design chromatographic method evaluation: a case study

AAPS Open ◽  
2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Yongzhi Dong ◽  
Zhimin Liu ◽  
Charles Li ◽  
Emily Pinter ◽  
Alan Potts ◽  
...  
Keyword(s):  
Quality By Design ◽  
Hplc Method ◽  
Original Method ◽  
Analytical Quality ◽  
Method Evaluation ◽  
Phase Gradient ◽  
Solid Models ◽  
Development And Validation ◽  
And Control

AbstractDesign of experiments (DOE)-based analytical quality by design (AQbD) method evaluation, development, and validation is gaining momentum and has the potential to create robust chromatographic methods through deeper understanding and control of variability. In this paper, a case study is used to explore the pros, cons, and pitfalls of using various chromatographic responses as modeling targets during a DOE-based AQbD approach. The case study involves evaluation of a reverse phase gradient HPLC method by a modified circumscribed central composite (CCC) response surface DOE.Solid models were produced for most responses and their validation was assessed with graphical and numeric statistics as well as chromatographic mechanistic understanding. The five most relevant responses with valid models were selected for multiple responses method optimization and the final optimized method was chosen based on the Method Operable Design Region (MODR). The final method has a much larger MODR than the original method and is thus more robust.This study showcases how to use AQbD to gain deep method understanding and make informed decisions on method suitability. Discoveries and discussions in this case study may contribute to continuous improvement of AQbD chromatography practices in the pharmaceutical industry.

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