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)
Recently, the concept and idea of “Quality by Design” (QbD) is attracting huge attention among pharmaceutical industries for maintaining Quality or for maintaining the appropriate quality standards in the products. It serves as a link between industrialists and drug regulatory officials to approach a scientific, risk-based, holistic, progressive approach to the development of pharmaceutical products. Its priorly focuses on designing and developing injectable hydrogel preparations from such manufacturing processes to ensure the predefined quality of the preparation. of the QbD elements include defining the target product quality profile, designing product and manufacturing processes, identifying critical quality attributes, process parameters, and sources of variability & controlling manufacturing processes to produce consistent quality over time The aim and purpose of this article is to discuss the concept of pharmaceutical Quality by Design implied on injectable hydrogels preparations and to explain that how it can be proven helpful to ensure pharmaceutical quality & formulation development.
Keywords:
Good manufacturing practices (GMP) Quality by Design (QbD), Target Product Quality Profile (TPQP), Critical Quality Attribute (CQA), Critical Process Parameter (CPP), and Quality Risk Management (QRM). INTRODUCTION
Cite Article:
"QUALITY BY DESIGN (QBD) IN PHARMACEUTICAL FORMULATIONS WITH SPECIAL EMPHASIS ON INJECTABLE HYDROGELS PREPARATIONS FROM DISCOVERY TO PRACTICE", International Journal of Novel Research and Development (www.ijnrd.org), ISSN:2456-4184, Vol.8, Issue 6, page no.e368-e379, June-2023, Available :http://www.ijnrd.org/papers/IJNRD2306448.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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