Quality by Design (QbD)

Top PDF Quality by Design (QbD):

Panoramic View on Quality by Design

Panoramic View on Quality by Design

Abstract: Quality by design (QbD) is an essential tool in pharmaceutical environment for having product/process/method impregnated with quality. Now, QbD is the greatest solution to construct quality in all pharmaceutical products, while in the same time making it as a part of system is also a key challenge for Industry. For understanding of QbD, it is very much essential to understand the desire product performance profile [Target product Profile (TPP), Target Product Quality Profile (TPQP)] and identify critical quality attributed (CQa). Basically, for meeting the product attributes, the product formulation and process can be designed on the basis of these stated parameters. Nonetheless, this helps in recognizing the effect of raw materials, critical material attributes (CMa), critical process parameters (CPP) on the CQas and identification and control sources of variability. The in and out understanding for QbD in generic pharmaceutical industry is really vital, because now and then FDa is taking firm stand to make mandatory “deadline” for inclusion of QbD. Therefore, an attempt has been made to highlight quality by design for generic drugs and its implications to pharmaceutical industry.
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QUALITY BY DESIGN: ITS APPLICATIONS

QUALITY BY DESIGN: ITS APPLICATIONS

Quality design (QBD) is a modern and systematic approach for product development and quality of pharmaceuticals. Quality by design is a concept first outlined by well known quality expert Joseph M. Juran. QBD is best key to build a quality in all pharmaceutical products, it is important to identify desire product performance report.QBD has it perspective to contribute the drug design, development, and manufacture of high quality drug product. Now-a –days the concept of Qbd can be extended to analytical techniques. In this analytical concept it is essential to define desire product performance profile, analytical target profile [ATP], identify critical quality attributes throughout designing and development process. The review aimed to identify implementation of QBD in analytical procedure validation. The outcomes of organized analytical process development and validation understand of critical quality attributes, risk assessment and outlining design space, and control strategy. The Quality by design is based on the ICH guidelines Q8 for pharmaceutical for development, Q9 Quality risk management, Q10 for pharmaceutical quality systems.
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QUALITY BY DESIGN   NOVELTY IN PHARMACEUTICALS

QUALITY BY DESIGN NOVELTY IN PHARMACEUTICALS

Quality by design is an essential part of the modern approach to pharmaceutical quality. Quality by Design (QbD) is everything you do to directly to promote, prove safety, efficacy and quality of your product from proof of concept to the point at which costumer are buying on regular basics. A new approach to drug development could increase efficiencies, provide regulatory relief and flexibility, and offer important business benefits throughout the product’s life cycle. QbD has become the answer to assist both industry and FDA to move towards a more scientific, risk based, holistic and proactive approach to pharmaceutical development. The concept promotes industry’s understanding of the product and manufacturing process starting with product development, basically building quality in and testing it. As results of all understanding, a company can continually monitor and update its manufacturing process to assure consistent product quality. Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. Product testing confirms the product quality. This systematic approach to product development and manufacturing has received a great deal from traditional approach, which was extremely empirical. Implementation of QbD is enabling transformation of the chemistry, manufacturing, and controls (CMC) review of Abbreviated New Drug Applications (ANDAs) into a modern, science and risk based pharmaceutical quality assessment.
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A brief review on Quality by Design [QbD] a Systematic Approach

A brief review on Quality by Design [QbD] a Systematic Approach

Abstract: Quality by Design is the modern approach for quality of pharmaceuticals. It describes use of Quality by Design to ensure quality of Pharmaceuticals. In this review Process parameters and quality attributes are identified for each unit operation. Benefits, opportunities and steps involved in Quality by Design of Pharmaceutical products are described. It is based on the ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, Q10 for pharmaceutical quality systems. Now-a- days the concept of QbD can be extended to analytical techniques. In this concept of QbD it is essential to define desire product performance profile, analytical target Profile and identify critical quality attributes throughout designing and development of a process. This review aimed to identify implementation of QbD in analytical procedure validation. The purpose of analytical QbD is to attain quality in measurement. it describes a multifactorial optimization of 4critical HPLC method parameters, i.e. gradient time(tG), temperature(T), pH and ternary composition (B1:B2) based on experiments. .The basic element is a gradient time temperature (tGT) plane, which is repeated at three different pH’s of the eluent A and at three different ternary compositions of eluent B between methanol and acetonitrile.”
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Stability-indicating Analytical Method Development using Quality by Design Approach for Simultaneous Estimation of Ezetimibe and Glimepiride

Stability-indicating Analytical Method Development using Quality by Design Approach for Simultaneous Estimation of Ezetimibe and Glimepiride

Quality by design (QbD) approach has been introduced by the Food and Drug Administration for the pharmaceutical development to ensure predefined quality attributes of the product. Simultaneously, the application of the QbD concept to the analytical method development leads to a more robust method. As per the International Conference on Harmonisation (ICH) Q8(R2) guidelines, QbD is defined as “a systematic approach to development that begins with predefined objectives and emphasizes product and process control, based on sound science and quality risk management”. Thus in this approach, the variables that overall contribute to the quality of the method are identified, their interactions are studied and finally a method with optimum values of the variables is developed [1] . Stability studies are an integral part
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Analytical quality by design (AQBD): new paradigm for analytical method development

Analytical quality by design (AQBD): new paradigm for analytical method development

The paradigm shift from OFAT to QbD (DoE) has supported the pharmacy professionals to cater the needs of combative Quality Assurance. Discerning the importance of analytical methods in pharmaceutical formulation development, the same principles should be applied to analytical method development also. The main endeavour of review is to focus on the use of aforementioned Design of Experiment concept in Research and Development and afterwards translation to Quality Assurance Department. The number of research publications reviewed in the paper endorses the fact. The designing increases the confidence in the method developed, as it covers all the aspects and compiles the results categorised under the Design Space. The initial process is costly but ultimately becomes cost effective in case of errors and risks. The benefits of Analytical Quality by Design concept are enormous. The main is during regulatory registration, the changes within the design space for the formulation development do not require refilling. So, to make the process of change in analytical method for registered product unproblematic, regulatory agencies should issue the guidelines pertaining to Analytical Quality by Design. The awareness in the professionals can be ensured by conducting various training programmes, workshops and awareness campaigns. Another important aspect is use of computer software for accurate statistical analysis of data. Cheaper reliable software accessibility will be appreciable. Thus, concluding with the remarks that Analytical Quality by Design is in infancy recently, will grow with regulatory control to its full potential.
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A Quality by Design Approach for Coating Process Parameter Optimization

A Quality by Design Approach for Coating Process Parameter Optimization

A few of the quality attributes for a final coated product could be the following; moisture content, surface roughness, gloss, coating efficiency, coating uniformity, colour uniformity and disintegration time. Thus, a process optimization study to identify the critical film coating parameters would be needed in order to ensure a robust process. Optimization of the process parameters were earlier done by one factor at a time (OFAT) approach but it was time consuming and less sensitive to parameter interactions. A quality by design (QbD) approach, involving multivariate analysis can be beneficial as the study can be done by variations of multiple factors at one time. There have been multiple studies directed towards identification and optimization of coating process parameters using QbD.
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Quality by Design Based RP HPLC for Simultaneous Estimation of Aspirin and Prasugrel HCL in  Marketed Formulation

Quality by Design Based RP HPLC for Simultaneous Estimation of Aspirin and Prasugrel HCL in Marketed Formulation

Presently the pharmaceutical industry is adopting the QbD concept to improve the robustness of manufacturing processes and to facilitate continuous improvement strategies, to shape and improve product quality and manufacturing productivity. As per ICH Q8 (R2) quality by design is defined as “"A systematic approach to development that starts with predefined goals and focuses on understanding products and processes and controlling processes, based on sound and quality risk management." [2] .
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Quality by design approach for simultaneous estimation of doxycycline hyclate and curcumin by RP-HPLC method

Quality by design approach for simultaneous estimation of doxycycline hyclate and curcumin by RP-HPLC method

Understanding the future requirements International Conference on Harmonization (ICH) proposed guidelines elaborating quality by design (QbD), quality by review, and risk assessment, viz ICH Q8, Q9 and Q10. Quality by design has become a new concept for developing and analyzing of quality pharmaceutical products. It is an essential part of modern approach to develop and analyze pharmaceutical product with quality attributes, QbD proves to be major solution to build quality in products but a major challenge to implement at an industrial scale [14] . Concept of quality by design lies
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Development and Validation of a Stability-indicating RP-HPLC Method Using Quality by Design for Estimating Captopril

Development and Validation of a Stability-indicating RP-HPLC Method Using Quality by Design for Estimating Captopril

The applicability of a quality by design framework for the development of a sensitive, simple and selective, stability-indicating reversed-phase high-performance liquid chromatography analytical method for the analysis of captopril was investigated. Design of experiments using a central composite design approach was used for method development. Twenty experimental runs were performed with acetonitrile content ranging between 28 and 36 % v/v, pH from 2.8 to 3.6 and temperature between 22° and 32°. The experimental data obtained was used to derive a quadratic model for the retention time of captopril. The optimized method produced sharp peaks with good resolution (>2) for captopril and the internal standard with retention times of 3.1 and 6.2 min, respectively. The experimental data revealed that acetonitrile content in the mobile phase and pH are significant factors that affect the retention time and resolution of captopril. Normal probability plots revealed that the residual and predicted data fall approximately on a straight line, indicating that the experimental error for these studies was evenly distributed suggesting that the model could be used to navigate the design space. This approach is useful to expedite method development and optimization activities in analytical laboratories.
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A quality by design approach on polymeric nanocarrier delivery of gefitinib: formulation, in vitro, and in vivo characterization

A quality by design approach on polymeric nanocarrier delivery of gefitinib: formulation, in vitro, and in vivo characterization

Furthermore, related to the applications of QbD in this study, few experimental runs used for the optimization are the evidence for reduction of manufacturing cost. The least values of residual error obtained are the evidence for reduc- tion of manufacturing variability. Small particle size, least PDI values, and smooth and spherical particles confirm the desired quality of gefitinib nanosuspension. Similarly, the Vero cell line studies of gefitinib nanosuspension confirmed the achievement of safety by the nanoformulation. On the basis of the obtained results as evidences, it can be concluded that QbD is a helpful tool in nanoparticulate drug delivery systems to reduce the manufacturing cost, reduce the manu- facturing variability, and improve the quality and safety, which is a primary requirement by USDFA.
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Nicotinamide polymeric nanoemulsified systems: a quality-by-design case study for a sustained antimicrobial activity

Nicotinamide polymeric nanoemulsified systems: a quality-by-design case study for a sustained antimicrobial activity

In this regard, the current study aimed at the preparation and evaluation of a nicotinamide-loaded Eudragit/cyclodextrin nanoemulsion in an attempt to standardize both its clinical efficacy and patient tolerability. Literature search showed scarce information about this investigation up to date. After proposing the QTPP and CQA of target drug product, Plackett–Burman (PB) screening design was employed as a statistically oriented methodology in determining the most influencing formulation and process parameters. It is our hypothesis that QbD-based preparation of nicotinamide in polymeric nanoemulsion might not only extend drug release rate but also sustain its antimicrobial activity, hence reducing the associated adverse effects. To challenge this hypothesis, 12 formulations of nicotinamide-loaded polymeric nano- emulsified particles were prepared using oil-in-water (O/W) emulsification technique with eight different chemical and physical factors. The formulations were then characterized in terms of encapsulation parameters, vesicular size (z-average) and size distribution, surface charge intensity, and drug release within 24 hours.
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QUALITY BY DESIGN (QBD): AN EMERGING PARADIGM FOR DEVELOPMENT OF PHARMACEUTICALS

QUALITY BY DESIGN (QBD): AN EMERGING PARADIGM FOR DEVELOPMENT OF PHARMACEUTICALS

Process Analytical Techniques (PAT): QbD combined with Process Analytical Technology (PAT) tools enable process control and increase the assurance that product quality attributes are achieved consistently, and/or that manufacturing efficiencies are obtained. PAT is one of the many tools or enablers of QbD. PAT can be an invaluable tool through life cycle management. During product and process development it can enhance prior knowledge and improve process understanding, help with process mapping and monitoring, model building and along with QRM, help establish a design space and a control strategy. During manufacturing operations PAT can help ensure process robustness and consistent output, as well as enabling operational flexibility through adaptive process controls, based on process understanding, and ultimately Real Time Release (RTR) through a science/risk based approach and Quality Systems. For continual improvement, PAT tools, such as multivariate data analysis and process control systems, enable historical data
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Uncovering interaction by QbD in Optimization of Stability-indicating HPLC Method for Simultaneous Estimation of Low Dose Aspirin and Lansoprazole

Uncovering interaction by QbD in Optimization of Stability-indicating HPLC Method for Simultaneous Estimation of Low Dose Aspirin and Lansoprazole

In the present study a quality by design acquiescent method utilizing design of experiment and method operable design regions methodology was evaluated for optimization of chromatographic condition for separation of ten degradation products along with peaks of aspirin and lansoprazole. Box-Behnken design was exploited to evaluate the main and interaction effects of the selected critical process parameters on the critical quality attributes, viz resolution between the peak pairs and retention time of last eluting peak. The optimal separation was predicted at pH 3.6, with a gradient starting at 20% of acetonitrile and initial hold time of 10 min. The results of experimental methods show excellent agreement with predicted results, highlighting the importance of design of experiments in method optimization. The selected working condition was then fully validated according to International Conference on Harmonisation guidelines for linearity, range, accuracy, precision and robustness.
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Emergence of Enhanced Quality Expectations in Pharmaceuticals

Emergence of Enhanced Quality Expectations in Pharmaceuticals

21st Century broke the static approach and FDA came up with new measurable guiding principles through real time quality monitoring approach, quality risk, quality management, quality by design approach, data integrity and quality metrics etc. etc. in its first 15 years. They emphasized on performance based regulatory approaches to concentrate on desired measurable outcomes instead of processes and procedures. It should navigate to improve quantitative quality performance of individuals and organizational behavior, such as through quality metrics and by building a quality culture. Unlikely, relying on testing the batches, building quality in the product to achieve clinical performance through specification acceptance criteria is the fundamental area of interest. Migration from traditional approach to enhanced approach for
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Comparison of Software Quality Models: An Analytical Approach

Comparison of Software Quality Models: An Analytical Approach

Quality is the total of features and characteristics of a product or a service that bears on its ability to satisfy the given needs (ANSI/ASQC A3/1978). Software quality has been categorized into two parts by Deutsch et al. [8] as software procedure quality and software product quality. Software engineering related elements like technology, tools, people, organisation and equipment were used in software procedure quality. However, software product quality consists of certain aspects like document clarity and integrity, design trace-ability, program reliability and test integrity as its basic characteristics. A quality model is usually defined as a set of characteristics and relationships between them which actually provide the basis for specifying the requirements of quality and evaluating quality [20]. It is also defined as a structured set of properties that are needed for an object of a class to meet defined purposes [12]. The benefit of quality model is given by decomposition of valuable object like process, product or organisation in the list of its characteristic/sub- characteristics measures. It is applicable for predicting, assuring and verifying the achievement of a defined goal. Quality, apart from describing and measuring the functional aspects of software also describes the extra functional properties such as how system is built and how it performs.
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An analysis of implementation of Taguchi method to improve production of pulp on hydrapulper milling

An analysis of implementation of Taguchi method to improve production of pulp on hydrapulper milling

2. Orthogonal Array: Used to design an exper- iment that efisisen and used to analyze ex- perimental data. Orthogonal array is used to determine the minimum number of experi- ments that can give as much information as possible all factors that influence the param- eter. The most important part of the orthog- onal array lies in the selection level combi- nation of input variables for each experiment.

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O'Reilly The Art of Agile Development pdf

O'Reilly The Art of Agile Development pdf

Except that it wasn’t quite that simple. Everything seemed fluid; people kept changing what they were working on. Jeff and Mary had gone backward, from requirements to planning, and all the programmers had jumped from integration and testing to design. He frowned. How was he going to keep track of it all? “Don’t worry,” said Kim quietly. She had noticed his discomfort. “It’s not as confusing as it seems. Jeff has it right: don’t worry about what to call what we’re doing. We’re all doing the same thing—getting stuff done. We work together to make it happen, and we jump back and forth between all the normal development activities as the situation dictates. If you focus on what we’re delivering rather than trying to figure out what phase of development we’re in, it will all make sense.”
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The quality of reporting in cluster randomised crossover trials: proposal for reporting items and an assessment of reporting quality

The quality of reporting in cluster randomised crossover trials: proposal for reporting items and an assessment of reporting quality

The cluster-level and individual-level characteristics can be either time invariant or time varying. For ex- ample, in a CRXO trial where hospital wards are rando- mised, the ward type (e.g. surgical, general medical) will remain constant for the duration of the trial. However, other cluster-level characteristics may vary, such as the type of clinicians working on the ward, due to staff changes (e.g. medical students and registrars moving in and out the ward). At the individual level, the character- istics of the individuals are likely to be time varying when new individuals are recruited across the periods (repeated cross-sectional design). However, if the trial is a cohort design, then individual-level characteristics such as sex will remain time invariant, while others, such as weight, may change over the duration of the trial.
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User group consultation: Design quality and project success

User group consultation: Design quality and project success

lessons from participatory design processes utilized in other sectors. User group consultation is part of a continuum of participatory design tools and techniques that have been used in many other sectors such as urban planning, community housing and workplace design in locations including the United States (US), United Kingdom (UK), and Europe (Luck, 2003). “Participatory design”, also known as “community participation” or “co-design”, has been written about extensively by authors such as Henry Sanoff and Rachael Luck (Luck, 2007; Sanoff, 1979, 1985, 1990). Blundell Jones, Petrescu, and Till (2005, p. xiii) noted that “architectural participation can be defined as the involvement of the user at some stage in the design process”, and that due to the multiplicity of users from different backgrounds and with differing agendas, multiple forms and methods encouraging participation will be necessary. This supports the claim of Reno et al. (2014) that it is necessary to create a shared language and understanding between members of multi-disciplinary teams as they evolve and take part in the planning process. Similarly, it confirms the warning of Hamilton (2010, p. 20) that authoritarian decision models may result in the making of poor decisions based on incorrect assumptions, whereas a collaborative decision style can utilize situation-specific expertise available from a greater range of team members. In summary, collaborative and participatory design processes can add a broader perspective, greater experience and expertise, and hence, increased value to the healthcare facility design process.
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