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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) |
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| Paper Title: | Review on QBD Quality by Design |
| Authors Name: | Pawar Meghanjali Shivaji , Waghmare Aarti Dnyandev |
| Download E-Certificate: | Download |
| Author Reg. ID: |
IJNRD_202912
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| Published Paper Id: | IJNRD2308017 |
| Published In: | Volume 8 Issue 8, August-2023 |
| DOI: | |
| Abstract: | A systemic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. QBD is a concept first outlined by Dr. Josep M. Juran EP Dr. Josep M. Juran explained that most of the quality crises and issues in the product are only due to the lack of importance of the product during product planning. QBD is described in ICH guidelines. Quality by Design is the modern approach to the quality of pharmaceuticals. This paper gives an idea about Pharmaceutical Quality by Design (QBD) and describes the use of Quality by Design to ensure the quality of Pharmaceuticals. The Quality by Design is described and some of its elements are identified. 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. The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the Product. |
| Keywords: | • QTPP- Quality Target Product Profile • CQA- Critical Quality Attributes • CMAs- Critical Material Attributes • Design Space • Process Parameters (PP) • Screening • Optimization |
| Cite Article: | "Review on QBD Quality by Design", International Journal of Novel Research and Development (www.ijnrd.org), ISSN:2456-4184, Vol.8, Issue 8, page no.a154-a160, August-2023, Available :http://www.ijnrd.org/papers/IJNRD2308017.pdf |
| Downloads: | 000118755 |
| 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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Published Paper ID:IJNRD2308017 Registration ID: 202912 Published In: Volume 8 Issue 8, August-2023 DOI (Digital Object Identifier): Page No: a154-a160 Country: Ahmednagar, Maharashtra, india Research Area: Pharmacy Publisher : IJ Publication Published Paper URL : https://www.ijnrd.org/viewpaperforall?paper=IJNRD2308017 Published Paper PDF: https://www.ijnrd.org/papers/IJNRD2308017 |
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ISSN: 2456-4184
Impact Factor: 8.76 and ISSN APPROVED
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