INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2456-4184 | Impact factor: 8.76 | ESTD Year: 2016
Scholarly open access journals, Peer-reviewed, and Refereed Journals, Impact factor 8.76 (Calculate by google scholar and Semantic Scholar | AI-Powered Research Tool) , Multidisciplinary, Monthly, Indexing in all major database & Metadata, Citation Generator, Digital Object Identifier(DOI)
Quality by Design is the ultramodern methodical approach in development of new
pharmaceuticals. It serves as link between industry and medicine non supervisory
authority. The aim of this article is to discuss the quality by design and emphasize how it
can be give pharmaceutical quality. It substantially defines and describe the quality by
design, literal background behind the QBD, pillars of QBD similar as -product design
thing, process design space, control space, operating space. It distinguishes between the
traditional approach and enhanced QBD approach. It concluding the key elements of QBD
including Quality target product profile (QTPP), critical quality attributes (CQAs) of drug
product, Quality risk management, critical material attribute and critical process
parameters, design space and control strategy along with various applications and benefits
of QBD.
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Keywords:
Quality target product profile (QTPP), Critical quality attributes (CQA), Quality by design (QBD), Quality risk management (QRM), Critical material attributes (CMA), Critical process parameters (CPP).
Cite Article:
"Quality By Design (QBD): A Modern Approach For Development of Quality Pharmaceuticals ", International Journal of Novel Research and Development (www.ijnrd.org), ISSN:2456-4184, Vol.7, Issue 12, page no.c423-c437, December-2022, Available :http://www.ijnrd.org/papers/IJNRD2212252.pdf
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ISSN:
2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar| ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.76 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator
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