Quality by Design for Distribution of Environmentally Sensitive Pharmaceutical Products

2015 ◽  
pp. 353-363
Author(s):  
Paul Harber
Keyword(s):  
Quality By Design ◽  
Pharmaceutical Products ◽  
Environmentally Sensitive

Quality by Design: Concept to Applications

2019 ◽  
Vol 16 (3) ◽  
pp. 240-250 ◽  
Author(s):  
Suryakanta Swain ◽  
Rabinarayan Parhi ◽  
Bikash Ranjan Jena ◽  
Sitty Manohar Babu
Keyword(s):  
Quality By Design ◽  
Pharmaceutical Products ◽  
Assessment Tools ◽  
Basic Knowledge ◽  
Target Product ◽  
Target Product Profile ◽  
Critical Material ◽  
Novel Approach ◽  
Product Profile ◽  
Performance Report

Background: Quality by Design (QbD) is associated with a modern, systematic, scientific and novel approach which is concerned with pre-distinct objectives that not only focus on product, process understanding but also lead to process control. It predominantly signifies the design and product improvement and the manufacturing process in order to fulfill the predefined manufactured goods or final products quality characteristics. It is quite essential to identify the desired and required product performance report, such as Target Product Profile, typical Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQA). Methods: This review highlighted the concepts of QbD design space, for critical material attributes (CMAs) as well as the critical process parameters that can totally affect the CQAs within which the process shall be unaffected thus, consistently manufacturing the required product. Risk assessment tools and design of experiments are its prime components. Results: This paper outlines the basic knowledge of QbD, the key elements; steps as well as various tools for QbD implementation in pharmaceutics field are presented briefly. In addition to this, quite a lot of applications of QbD in numerous pharmaceutical related unit operations are discussed and summarized. Conclusion: This article provides a complete data as well as the roadmap for universal implementation and application of QbD for pharmaceutical products.

Quality by design: A Roadmap for quality pharmaceutical products

2019 ◽  
Vol 8 (2) ◽  
pp. 289
Author(s):  
MayurA Chordiya ◽  
HemantH Gangurde ◽  
VikramN Sancheti
Keyword(s):  
Quality By Design ◽  
Pharmaceutical Products

Implementation of Quality by Design: A Review

2019 ◽  
Vol 6 (2) ◽  
pp. 99-111
Author(s):  
Deepika Purohit ◽  
Manisha Saini ◽  
Parijat Pandey ◽  
Swagat Tripathy ◽  
Harish Dureja
Keyword(s):  
Quality By Design ◽  
Generic Drugs ◽  
Therapeutic Benefit ◽  
Pharmaceutical Products ◽  
In Vitro Tests ◽  
Performance Quality ◽  
The Status ◽  
Regulatory Bodies

Background: In pharmaceutical terms, quality means a product free from any contamination and delivers the therapeutic benefit specified in the label at a reproducible rate which can be assessed by carrying out in vivo or in vitro tests for evaluation of performance. Quality by Design (QbD) is a necessary tool in pharmaceutical environment for having product/process/method impregnated with quality. QbD is a move toward drug development that ensures the preplanned product specifications by providing guidance for architecting the manufacturing processes and formulation. Methodology: It has provided the solution to support both the regulatory bodies and industry to shift towards added proactive and scientific approach. QbD is the greatest solution to construct quality in all pharmaceutical products, while at the same time, making it a part of the system is also a key challenge for the industry. By using QbD concept, regulators as well as industries are making a move in geometric progress in bringing quality products. Regulatory bodies across the world are showing significant attention to QbD. Conclusion: Therefore, an attempt has been made to highlight quality by designing generic drugs and its implications to pharmaceutical industry including clinical trials, pharmaceutical validation processes and in biologics and also to provide a brief description on the status of QbD in India and as well as in Asia.

scholarly journals Analytical Quality by Design

2021 ◽  
Vol 8 (32) ◽  
pp. 1-5
Author(s):  
Márcia Breitkreitz
Keyword(s):  
Manufacturing Process ◽  
Quality By Design ◽  
Pharmaceutical Products ◽  
Quality Parameters ◽  
Regulatory Agencies ◽  
Regulatory Requirements ◽  
Significant Step ◽  
Level Of Understanding ◽  
High Level

Throughout the 20th century, the notion of ‘quality’ underwent major changes. The concept of ‘Quality by Testing’, i.e. evaluating the quality of a product by testing it for some pre-defined parameters after completing the manufacturing process, started to be replaced by the enhanced approach of Quality by Design (QbD). In this concept, idealized by Joseph Juran [1], quality is initially conceived for the product, and then the product is manufactured and evaluated to reach that quality. Driven by the need to reduce costs and to encourage companies to improve their understanding of their products and manufacturing processes, pharmaceutical regulatory agencies, through the ICH (International Council on Harmonization), published the ICH Q8 guideline, highlighting the QbD strategy for pharmaceutical development [2]. This represented a significant step in replacing the existing quality paradigms in the conventional manufacturing of pharmaceutical products and paved the way to support development and production activities within a scientific, flexible environment, with a high level of quality, without the need for extensive regulatory surveillance. The higher level of understanding gained during development allows out-of-specification batches to be foreseen and ensures that the desired quality will be obtained at the end of the manufacturing process. The two pillars of the QbD concept are quality risk management and multivariate study of the outcomes (quality parameters) as functions of the inputs (materials, formulation and process inputs). At this point, Chemometrics emerged officially as a strategy to support the pharma regulatory requirements- the beginning of a joyful and long-life union.

Quality by Design applications in biosimilar pharmaceutical products

2008 ◽  
Vol 13 (12) ◽  
pp. 681-690 ◽  
Author(s):  
Ron S. Kenett ◽  
Dan A. Kenett
Keyword(s):  
Quality By Design ◽  
Pharmaceutical Products

scholarly journals Quality by Design: A new practice for production of pharmaceutical products

2019 ◽  
Vol 9 (1-s) ◽  
pp. 416-424
Author(s):  
Anuj Malik ◽  
Gourab Gochhayat ◽  
Md Shamshir Alam ◽  
Manish Kumar ◽  
Preeti Pal ◽  
...  
Keyword(s):  
Product Quality ◽  
Quality By Design ◽  
Full Range ◽  
Pharmaceutical Products ◽  
Pharmaceutical Product ◽  
Quality Item ◽  
Ich Guidelines ◽  
Quality Profile ◽  
Item Quality ◽  
Basic Quality

This is the advanced approach for development of pharmaceutical product with full range and specified limits of variables during procurements, storage and manufacturing process with a qualification, at desired level of quality within the limits of low and higher values of variables to ensures  the Pharmaceutical product Quality by design (QbD) of manufacturing a finished product. The Quality by Design is depicted and a portion of its components recognized and process parameters with quality characteristics are identified for every unit activity. Advantages, openings and steps engaged with Quality by Design of Pharmaceutical items are depicted. The point of the pharmaceutical advancement is to plan a quality item and it’s assembling procedure to reliably convey the proposed execution of the item. Quality can't be tried into items however quality ought to be worked in by outline. It incorporates the Quality target item profile, basic quality traits and key parts of Quality by Design. It likewise gives correlation between item quality by end item testing and item quality by Quality by Design. The establishment of Quality by Design is ICH Guidelines. It depends on the ICH Guidelines Q8 for pharmaceutical improvement, Q9 for quality hazard administration, Q10 for pharmaceutical quality frameworks. It moreover gives utilization of Quality by Design in pharmaceutical improvement and assembling of pharmaceuticals. Keywords: Quality by Design, Design Space, Target Product Quality Profile, Critical Quality Attributes

QUALITY BY DESIGN: AN OVERVIEW

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (02) ◽  
pp. 5-11
Author(s):  
S Suresh ◽  
◽  
S. Roy ◽  
B. K Ahuja
Keyword(s):  
Manufacturing Process ◽  
Quality By Design ◽  
Pharmaceutical Products ◽  
Point Of View ◽  
Assessment Tools ◽  
Successful Implementation ◽  
Critical Material ◽  
Road Map ◽  
Process Understanding ◽  
Critical Material Attributes

Quality by Design (QbD) is a systematic, scientific, holistic and proactive approach that begins with pre-defined objectives and emphasis on product, process understanding and process control. It essentially necessitates designing and developing the product and the manufacturing process to achieve the predefined product quality objectives. QbD identifies characteristics that are vital to quality from the patient’s point of view and converts them into critical quality attributes (CQAs) that the product should possess. Further, it establishes the limits, the design space, for critical process parameters (CPPs) and critical material attributes (CMAs) that affect the CQAs within which the process will be unaffected and consistently manufacture the desired product. This knowledge is then used to implement a flexible and robust manufacturing process that can adapt and yield a stable product. Risk assessment tools and design of experiments (DoE) are its integral components. This article gives a road map for successful implementation of QbD for pharmaceutical products.

Quality by Design in Pharmaceutical Formulation

2019 ◽  
pp. 221-239
Author(s):  
Sundaramurthy Vivekanandan
Keyword(s):  
Quality By Design ◽  
Drug Product ◽  
Quality Attributes ◽  
Pharmaceutical Products ◽  
Design Approach ◽  
Critical Quality Attributes ◽  
Quality Product ◽  
Product Profile ◽  
Critical Material Attributes ◽  
Quality By Design Approach

Quality by design (QbD) is a systematic, scientific, risk-based approach to product development and manufacturing process to consistently deliver the quality product. In this chapter, application, benefits, opportunities, regulatory requirements involved in quality by design of pharmaceutical products are discussed. In quality by design approach, during development, the developer defines quality target product profile (QTPP) and identifies critical quality attributes (CQA). Critical process parameters (CPP) of unit operations which impacts critical quality attributes need to be identified to understand the impact of critical material attributes (CMA) on quality attributes of the drug product. Quality by design approach is defined in ICH guidelines Q8 – Pharmaceutical Development, Q9 – Quality Risk Management, Q10 – Pharmaceutical Quality System. This chapter describes the implementation of new concepts in quality by design like design of experiments to achieve design space, control strategy to consistently manufacture quality product throughout the product lifecycle.

Sign in / Sign up

Export Citation Format

Share Document