Understanding Pharmaceutical Quality by Design
نویسندگان
چکیده
منابع مشابه
Pharmaceutical “quality by design” approach
10.4103/japtr.JAPTR_343_17 Dear Friends, Based on quality risk management, the pharmaceutical quality by design (QbD) has been emerged as a logical methodology for the development which commences with prior delineated goals and accentuates better understanding of product and process control. The basis of QbD strategy is International Conference on Harmonization guidelines. QbD approach is surfa...
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The purpose of present article is to discuss the concept of pharmaceutical Quality by Design (QbD) and describe how it can be help to ensure pharmaceutical quality. Quality by design is an essential part of the modern approach to pharmaceutical quality. The elements of quality by design are examined and a consistent nomenclature for quality by design, critical quality attribute, critical proces...
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OBJECTIVES In this study, the principles of quality by design (QbD) have been uniquely applied to a pharmaceutical melt extrusion process for an immediate release formulation with a low melting model drug, ibuprofen. METHODS Two qualitative risk assessment tools - Fishbone diagram and failure mode effect analysis - were utilized to strategically narrow down the most influential parameters. Se...
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Pharmaceutical industry is showing a positive approach towards Quality by Design (QbD) for discovery, development, and commercial manufacturing of biopharmaceutical products. Regulatory agencies are providing various guidelines for pharmaceutical industry to build quality, safety and efficacy into their new biopharmaceutical products. Such concept became known as Quality by Design. To assess th...
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Most mature organisations regularly undertake varying forms of business improvement activities, from specific operationally focused project activities to organisation-wide change initiatives. While the success of business improvement approaches is often debated, such initiatives always leave some form of trace or legacy behind, often in the form of specific processes and procedures, individual ...
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ژورنال
عنوان ژورنال: The AAPS Journal
سال: 2014
ISSN: 1550-7416
DOI: 10.1208/s12248-014-9598-3