Technology & Engineering
Quality by Design
Quality by Design (QbD) is a systematic approach to product development that focuses on designing quality into the product from the outset. It involves identifying critical quality attributes, understanding and controlling the manufacturing process, and using risk management to ensure consistent quality. QbD aims to enhance product quality, reduce variability, and minimize the need for post-production testing and corrective actions.
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10 Key excerpts on "Quality by Design"
eBook - ePubCost-Contained Regulatory Compliance
For the Pharmaceutical, Biologics, and Medical Device Industries
- Sandy Weinberg(Author)
- 2011(Publication Date)
- Wiley(Publisher)
Secondly, QbD is logically consistent. It provides a rational framework for controlling quality in production, search, laboratories, and other requirements, with a reasonable and defensible system of tolerances and permissible variants. QbD makes good sense for the management of an automated laboratory: Understand the processes involved, measure the performance of those processes, and interpret those measurements in a risk construct.With reasonable assurance, a QbD approach to laboratory quality control and assurance will be the dominant paradigm of the future. 4.10 SUMMARYQuality by Design (QbD) is an evolving initiative of the US Food and Drug Administration, simplified from more extensive and rigorous methodologies of the same name in use in the general manufacturing engineering industries. In its current configuration, QbD includes (a) the use of a Risk Assessment to determine which variables and parameters are most important in the quality control of a product, (b) the use of a Design Space analysis to determine the effective range or variance of those variables, and (c) the use of a Process Analytical Technology approach to continuously monitor and cyberneticly adjust those variables. Once implemented, QbD can greatly improve quality assurance and control while containing costs; the investment necessary to cd xposition a system for QbD varies widely. It is likely to represent a cost increase (with reasonable payback period) until regulatory guidelines and/or industry standards force that investment.Quality by Design is therefore likely to represent a short-term cost increase but a long-term effective cost containment strategy, and it is likely to be a mandatory norm within the next two to five years.Notes1 Kamm, J. Can You Win the Space Race? Pharmaceutical Manufacturing, May 2007.2 Weinberg, S. Early Warning: Attitude Adjustment at FDA, American Biotechnology Laboratory, July 2003.3
eBook - PDFPharmaceutical Dosage Forms - Parenteral Medications
Volume 3: Regulations, Validation and the Future
- Sandeep Nema, John D. Ludwig(Authors)
- 2016(Publication Date)
- CRC Press(Publisher)
risk, establishing process boundaries to understand and reduce variability and developing holistic control strategies in a prospective focus toward continual improvement. WHAT DOES Quality by Design MEAN? The paradigm shift or change in orientation toward adoption and application of QbD principles has been acknowledged by several companies who have incorporated the approach as an integral part of their business. For example, once clinical proof of concept has been demonstrated for a product, development project teams embark on systematic and scientific/ risk-based design of the commercial product formulation and process, where elements of QbD are integral to development as illustrated in Figure 2 (29). From company to company, the sequence may vary in detail and formality, but the elements of the approach are essentially the same. The therapeutic profile of a medicinal candidate and its preliminary quality criteria provide the definition of the product and its intended use. The properties of the drug substance are confirmed and analyzed and, in conjunction with “prior knowledge,” form the basis for understanding material attributes that lead to formulation design. An assessment of the formulation in consideration of prior relevant knowledge and experience may reveal functional relationships between material properties and quality attributes that may warrant experiments to establish important properties and characteristics of the formulated product and their influence on quality. Likewise, design of the manufacturing process with subsequent assessment in conjunction with prior relevant knowledge and experience may reveal functional relationships between process parameters and quality attributes. These functional relationships may lead to experiments that establish design space, whose boundaries can contribute to the understanding and development of control strategy.
eBook - ePubQuality in the Era of Industry 4.0
Integrating Tradition and Innovation in the Age of Data and AI
- Kai Yang(Author)
- 2023(Publication Date)
- Wiley(Publisher)
Design Quality: This denotes the value that a design offers to customers. As the output of design spans products, services, and user experiences, design quality or the quality of the design corresponds to the degree of excellence or value of these outputs. Design is the origin of all qualities, extending to the quality of products, services, and experiences. Design quality encapsulates all dimensions of quality including functionality, usability, reliability, performance, safety, esthetics, and more. Factors such as customer satisfaction, brand perception, sales volume, market share, reliability, and performance often serve as metrics to assess design quality.- Quality by Design: This term signifies a dedicated approach to product development and manufacturing that emphasizes embedding quality at each stage, with a particular focus on the initial stages of the product life cycle. Quality by Design incorporates innovation and QA into the design and development process instead of relying on quality control in manufacturing and post‐production inspections and rectifications.
The role of design in the product life cycle has been underscored by scholars across disciplines like innovation/R&D management, operations management, and marketing management. There is substantial agreement across these fields on the substantial contribution of design to the competitive performance of a product and a company [3 , 33 , 34 ]. The field of quality management and quality engineering is also witnessing a growing recognition of “Quality by Design” as an effective and significant approach to achieve superior quality. The success stories of Apple Inc. and Samsung offer prime examples of this.A pressing question in the current scenario, as we transition into the era of Industry 4.0, is how will we implement “Quality by Design”? Before delving into this, let us first understand the changes brought about by Industry 4.0.3.4.2 Some Significant Changes in Business Ecosystem in Digital Revolution
Just as humans and animals exist within ecosystems in nature, businesses operate within their own ecosystems. A business ecosystem comprises a multifaceted network of individuals, organizations, and technologies, all interconnecting to create, deliver, and capture value. It encapsulates every actor involved in the conception and provision of a specific product or service, as well as the supporting technologies and infrastructure. While the constituents of a business ecosystem vary depending on the specific industry and market, they typically include the following:
- Jelena Duris, Jelena Djuris(Authors)
- 2013(Publication Date)
- Woodhead Publishing(Publisher)
1Quality-by-design in pharmaceutical development
Jelena Djuris, Svetlana Ibric and Zorica Djuric, Department of Pharmaceutical Technology and Cosmetology Faculty of Pharmacy University of BelgradeAbstract:
This first chapter introduces the concept of quality-by-design (QbD) and its role in pharmaceutical product development. QbD assures the quality of a pharmaceutical product through scientific development and risk management tools, and will eventually enable real-time release, regardless of the formulation type. Several guidelines on pharmaceutical development, quality risk management, and pharmaceutical quality systems are presented that are applicable throughout the product lifecycle. Design space appointment and control strategies for risk management are introduced. The meaning of the QbD concept is presented from both regulatory and manufacturers’ points of view. Several illustrative examples are provided to facilitate the understanding of the QbD concept and ease of its application.Key words quality-by-design (QbD) design space risk management tools control strategies1.1 Introduction
The pharmaceutical industry is one of the most strictly regulated and its products are of excellent quality. However, there are issues suggesting that pharmaceutical development and manufacturing can be improved. These facts are especially noticeable in cases of batch failures and reworks, regulatory issues, implementation of new technologies, etc. The current state of the pharmaceutical industry, in terms of yield and defects (e.g. relation of quality and productivity), is not comparable to some of the more advanced industries (e.g. the semiconductor industry). Defects in pharmaceutical product quality can be encountered such as low manufacturing process yield or, more dangerously, some which may affect the therapeutic performance of the drug (or both). For some products, waste can be as high as 50%. Furthermore, the effects of scale-up on the final product are often not understood and reasons for manufacturing failures are not analyzed (Shah, 2009 ). The quality of a pharmaceutical product can be defined as an acceptably low risk of failing to achieve the desired clinical attributes of the drug (Shah, 2009
eBook - PDF- Taosheng Chen, Sergio C. Chai, Taosheng Chen, Sergio C. Chai(Authors)
- 2016(Publication Date)
- IntechOpen(Publisher)
design of the products with fewer problems in manufacturing; allows for the implementation of new technology to improve manufacturing without regulatory scrutiny; and ensures less complication during review, so that reduced deficiencies and quicker approval is possible [17]. Another benefit often noted is the promise of less burdensome regulatory reporting of postapproval changes. Even without the incentive of less burdensome regulatory oversight [3]. 4. Quality by Design approach for biotechnology products As in past few decades, manufacturers define a process and aim to perform the process consistently in a way that the critical parameters are controlled within a narrow range in order to reduce versatility in product quality for biotechnology products. However, because the process controls are fixed in this approach, any variability in raw materials, environmental controls, and/or process operations manifests as variability in product quality and results in lot failures [19]. The international ICH Q8 (R2), Q9, and Q10 guidelines provide the foundation for implementing QbD to the biotech products, however, involve some differences and complexities [5]. A key element in implementing QbD for biotechnology products is engineering the mole‐ cule itself. A number of strategies are currently used by investigators to alter the proper‐ ties of the molecule to achieve the desired balance among efficacy, stability, safety, and manufacturability. Realization of the structure and functional attributes of therapeutic pro‐ teins, including monoclonal antibodies (MAbs), is crucial to create the design space, be‐ cause that understanding facilitates the selection of requested quality attributes through the molecular design while ensuring that bioactivity of the protein therapeutic is main‐ tained [5]. There is a need for certain technologies and processes for QbD implementation in the bio‐ pharmaceutical industry.
eBook - ePubPharmaceutical Quality by Design
Principles and Applications
- Sarwar Beg, Md Saquib Hasnain(Authors)
- 2019(Publication Date)
- Academic Press(Publisher)
Chapter 1Introduction to Quality by Design (QbD): Fundamentals, Principles, and Applications
Sarwar Beg* ; Md Saquib Hasnain† ; Mahfoozur Rahman‡ ; Suryakanta Swain§ * Department of Pharmaceutics, School of Pharmaceutical Education and Research (SPER), Jamia Hamdard (Hamdard University), New Delhi, India† Department of Pharmacy, Shri Venkateshwara University, Gajraula, India‡ Department of Pharmaceutical Sciences, Shalom Institute of Health and Allied Sciences, Sam Higginbottom University of Agriculture, Technology & Sciences (SHUATS), Allahabad, India§ Southern Institute of Medical Sciences, College of Pharmacy, Department of Pharmaceutics, SIMS Group of Institutions, Guntur, IndiaAbstract
Pharmaceutical quality has been under long debate for decades. In the current scenario of regulatory environments, the pharmaceutical industry is continuously facing challenges with respect to achieving the desired quality of drug products. The two major issues highlighted over the years include poor cGMP compliance and lack of understanding regarding the product and process parameters. This has ultimately generated consumer skepticism regarding the quality of pharmaceutical products, especially the generic medicines. Hence, the global regulatory agencies such as ICH and USFDA took initiatives by implementing the culture of quality for improving manufacturing standards. In this context, the pharmaceutical industry has undergone a paradigm shift from traditional quality by testing (QbT) to the systematic Quality by Design (QbD) approach for attaining efficient development of drug products with enhanced quality and resource economics. Recently, QbD has been considered as a lifecycle approach, as it is omnipresent at all stages of the product development. The present book chapter, in this regard, endeavors to provide an overview account on various facets of QbD in pharmaceutical development for ultimately attaining manufacturing excellence and regulatory compliance.
- David J. am Ende, Mary T. am Ende, David J. am Ende, Mary T. am Ende(Authors)
- 2019(Publication Date)
- Wiley(Publisher)
Identifying and managing risks to product quality is crucial to ensuring the safety and efficacy of pharmaceutical products. Chemical engineers often have a key role in conducting or contributing to these QRAs. QbD is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and QRM. The goals of QbD typically include: The definition of meaningful product quality specifications based on clinical performance. Improved process capability and reduction of product variability and defects through enhancing product and process design, understanding, and control. Improved development and manufacturing efficiency. Enhanced capability for root cause analysis and post‐approval change management. In particular, QbD is dependent on effective use of risk assessment and management tools (ICH Q9 Quality Risk Management [2]) and needs to be accompanied by good development science (ICH Q8(R2) Pharmaceutical Development [1] and ICH Q11 Development and Manufacture of Drug Substance [3]) and at an appropriate stage integrated into a suitable quality system (ICH Q10 Pharmaceutical Quality System [4]). Prior to assessing risks to quality, the quality requirements for the drug product and drug substance need to be understood. ICH Q8 [1] indicates that this can be done by “Defining the quality target product profile (QTPP) as it relates to quality, safety and efficacy, considering e.g., the route of administration, dosage form, bioavailability, strength, and stability.” Delineating the QTPP allows definition of potential drug product critical quality attributes (CQAs). Some of the drug product CQAs will be linked only to aspects of the drug product process, but typically several are linked back to drug substance and excipient CQAs, for example, purity and powder properties
eBook - ePubQuality by Design for Biopharmaceuticals
Principles and Case Studies
- Anurag S. Rathore, Rohin Mhatre, Anurag S. Rathore, Rohin Mhatre(Authors)
- 2011(Publication Date)
- Wiley-Interscience(Publisher)
Given that the most frequently quoted reason for reluctance to introduce innovations was the regulatory environment, the FDA established several initiatives, including the process analytical technology (PAT) initiative, with the objective of removing obstacles to innovations which could lead to superior quality and manufacturing efficiencies. PAT is essentially an approach to secure quality and process consistency through a combination of process understanding and real-time responsive control. It begins with initial process design, allows dynamic processing, minimizes waste, and supports continuous improvement throughout the product life cycle.More recently, additional communications from the FDA have focused on the broader area of pharmaceutical cGMPs for the twenty-first century, and ICH guidelines have further developed the concepts of Quality by Design (QbD) and design space. The original FDA PAT team has been restructured, leaving some to wonder if the original commitment to PAT and the promise of regulatory flexibility still stand.In this chapter, we shall review briefly the development of PAT and QbD in FDA, EMEA, and ICH guidelines, describe how industry initiatives in developing standards and guidelines are intended to support and elaborate on the guidelines, and discuss approaches for the implementation of PAT in securing quality, reducing variability, and supporting continuous improvement in biotechnology processes.13.2 EVOLUTION OF PAT AND Quality by Design (QbD): EMERGING GUIDELINES AND STANDARDSTo understand how the emphasis may have seemed to shift away from PAT, it is helpful to consider the broad time line of events as the agency developed its program to reshape the way in which the pharmaceutical industry approached lifecycle management of manufacturing science and technology (Fig. 13.1 ), see also Chapter 2.In summary, although the initial dialogue seemed to focus mostly on PAT [1, 2], as the agency produced additional documents [3, 4] it became apparent that although the agency continued to state its support for PAT, the PAT initiative was part of a grander scheme to address quality, and what was perceived as stagnation in the delivery of new therapies and in manufacturing technology and innovation. In 2005, the agency initiated the Office of New Drug Quality Assessment (ONDQA) CMC Pilot Program to revamp the way in which filings were submitted and reviewed. The new Pharmaceutical Quality Assessment System (PQAS) placed greater emphasis on scientific knowledge and understanding of the product and process by applying Quality by Design principles, and built on the team-based integrated review and assessment process that was developed for PAT; companies were encouraged to file applications under the new system with an agreement that if the appropriate level of process and product understanding was demonstrated, then the companies would be free to make changes within the approved design space based on internal quality systems and GMP controls.
- Ming-Li Shiu, Jui-Chin Jiang, Mao-Hsiung Tu(Authors)
- 2013(Publication Date)
- Wiley(Publisher)
1.3 HOW TO DESIGN FOR QUALITY As mentioned above, we classify quality into two types: customer-driven quality and engineered quality. Therefore, the design methodologies needed to realize the quality of the two types are also different. In late 1960s, when Japanese products started the period from “designed by imitation” to “developed by originality,” the so-called “customer-driven quality” becomes important; that quality is the quality built into the product according to the voice of the customer (VOC). Also, customer-driven quality can be further described based on the definition of quality, “fitness for use,” defined by Juran (1992). The “fitness for use” defined by Juran includes both meanings of “product features” and “freedom from deficiencies”; that is, it expresses that customer satisfaction is determined by how the product achieves the balance between more features and fewer deficiencies, and that balance state is quality. To achieve customer-driven quality and improve cus-tomer satisfaction, a quality assurance (QA) method called quality function deployment (QFD) applied to NPD was developed; it can effectively convert 6 INTRODUCTION TO Quality by Design VOC into quality characteristics as well as their design targets, as well as deploy various subsystems, components, parts, and process elements and facili-tate the interrelationships needed to achieve those targets. The so-called quality function deployment (broadly defined) is actually the short form of both “quality deployment” and “quality function deployment (narrowly defined)”; the former is the method used to ensure product quality, and the latter is used to ensure work quality and process quality (“quality function” means the job functions that create quality). QFD is considered as a compre-hensive approach to function design and quality deployment.
eBook - PDFQuality in the Era of Industry 4.0
Integrating Tradition and Innovation in the Age of Data and AI
- Kai Yang(Author)
- 2023(Publication Date)
- Wiley(Publisher)
3 Quality by Design and Innovation 114 4 Morgan, J. and Liker, J.K. (2020). The Toyota Product Development System: Integrating People, Process, and Technology. CRC Press. 5 Taguchi, G. (1995). Quality engineering (Taguchi methods) for the development of electronic circuit technology. IEEE Transactions on Reliability 44 (2): 225–229. 6 Kackar, R.N. (1985). Off-line quality control, parameter design, and the Taguchi method. Journal of Quality Technology 17 (4): 176–188. 7 Yang, K. and El-Haik, B.S. (2009). Design for Six Sigma: A Roadmap for Product Development. McGraw-Hill Education. 8 Jenab, K., Wu, C., and Moslehpour, S. (2018). Design for six sigma: a review. Management Science Letters 8 (1): 1–18. 9 Watson, G.H. and DeYong, C.F. (2010). Design for Six Sigma: caveat emptor. International Journal of Lean Six Sigma 1 (1): 66–84. 10 Chowdhury, S. (2002). Design for Six Sigma. Kaplan Business. 11 Chang, S.-J. (2011). Sony Vs Samsung: The Inside Story of the Electronics giants’ Battle for Global Supremacy. Wiley. 12 Song, J. and Lee, K. (2014). The Samsung Way: Transformational Management Strategies from the World Leader in Innovation and Design. McGraw Hill Professional. 13 Lee, K.-C. and Choi, B. (2006). Six Sigma management activities and their influence on corporate competitiveness. Total Quality Management & Business Excellence 17 (7): 893–911. 14 Shahin, A. (2008). Design for Six Sigma (DFSS): lessons learned from world-class companies. International Journal of Six Sigma and Competitive Advantage 4 (1): 48–59. 15 Yang, K. and Cai, X. (2009). The integration of DFSS, lean product development and lean knowledge management. International Journal of Six Sigma and Competitive Advantage 5 (1): 75–99. 16 Al’tshuller, G.S. (1999). The Innovation Algorithm: TRIZ, Systematic Innovation and Technical Creativity. Technical Innovation Center, Inc. 17 Willyard, C.H. and McClees, C.W. (1987). Motorola’s technology roadmap process. Research Management 30 (5): 13–19.
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