Analytical quality by design: a tool for regulatory flexibility and robust analytics.
TLDR
This paper has been communicated to discuss different views of analytical scientists about implementation of AQbD in pharmaceutical quality system and also to correlate with product quality by design and pharmaceutical analytical technology (PAT).Abstract:
Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allows the analytical method for movement within method operable design region (MODR). Unlike current methods, analytical method developed using analytical quality by design (AQbD) approach reduces the number of out-of-trend (OOT) results and out-of-specification (OOS) results due to the robustness of the method within the region. It is a current trend among pharmaceutical industry to implement analytical quality by design (AQbD) in method development process as a part of risk management, pharmaceutical development, and pharmaceutical quality system (ICH Q10). Owing to the lack explanatory reviews, this paper has been communicated to discuss different views of analytical scientists about implementation of AQbD in pharmaceutical quality system and also to correlate with product quality by design and pharmaceutical analytical technology (PAT).read more
Citations
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Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD)
Isa Martins Fukuda,Camila Francini Fidelis Pinto,Camila dos Santos Moreira,Alessandro Morais Saviano,Felipe Rebello Lourenço +4 more
TL;DR: This review illustrates the principles and applications of the most common screening designs; and optimization designs, such as three-level full factorial, central composite designs (CCD), and Box-Behnken designs.
Journal ArticleDOI
Pharmaceutical product development: A quality by design approach.
TL;DR: The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space.
Journal ArticleDOI
Development and Optimization of Liquid Chromatography Analytical Methods by Using AQbD Principles: Overview and Recent Advances
TL;DR: This review presents the Analytical quality by Design concept, an extension of Quality by Design (QbD), which was introduced in 2004 by the U.S. Food and Drug Administration (FDA) and approv...
Journal ArticleDOI
Recombinant Proteins for Industrial versus Pharmaceutical Purposes: A Review of Process and Pricing
John Puetz,Florian M. Wurm +1 more
TL;DR: Manufacturing techniques are reviewed and the major reason for the very high pricing of pharma protein products does not reflect CoG, but the financial obligations of clinical trials, research and development, patent constraints, marketing, and return on investment.
Journal ArticleDOI
Risk-based approach for method development in pharmaceutical quality control context: A critical review.
TL;DR: The AQbD workflow and its application in the development of methods to be used for pharmaceutical quality control have been treated and discussed and the different development strategies have been showcased, highlighting their advantages and disadvantages, in order to give a useful overview.
References
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Development of quality‐by‐design analytical methods
TL;DR: In this review, the current state of analytical QbD in the industry is detailed with examples of the application of analyticalQbD principles to a range of analytical methods, including high-performance liquid chromatography, Karl Fischer titration for moisture content, vibrational spectroscopy for chemical identification, quantitative color measurement, and trace analysis for genotoxic impurities.
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Application of quality by design to the development of analytical separation methods
TL;DR: The application of QbD concepts to the development of analytical separation methods, for example chromatography and capillary electrophoresis, is outlined, emphasizing the main differences from the traditional quality by testing (QbT) approach.
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Quality by Design: Multidimensional exploration of the design space in high performance liquid chromatography method development for better robustness before validation.
TL;DR: This work presents the systematic development of an optimal, robust, fast UHPLC method for the simultaneous assay of two APIs of an eye drop sample and their impurities, in accordance with Quality by Design principles.
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Aspects of the "Design Space" in high pressure liquid chromatography method development.
TL;DR: A multifactorial optimization of 4 critical HPLC method parameters, i.e. gradient time, temperature, pH and ternary composition was carried out in such a way as to systematically vary all four factors simultaneously.