Paper Title
QUALITY BY DESIGN (QBD) IN PHARMACEUTICAL FORMULATIONS WITH SPECIAL EMPHASIS ON INJECTABLE HYDROGELS PREPARATIONS FROM DISCOVERY TO PRACTICE
Article Identifiers
Authors
Dixit Thakur , Ankita Pokhriyal
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
Abstract
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.
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How To Cite (APA)
Dixit Thakur & Ankita Pokhriyal (June-2023). 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, 8(6), e368-e379. https://ijnrd.org/papers/IJNRD2306448.pdf
Issue
Volume 8 Issue 6, June-2023
Pages : e368-e379
Other Publication Details
Paper Reg. ID: IJNRD_199670
Published Paper Id: IJNRD2306448
Downloads: 000121974
Research Area: Pharmacy
Country: dehradun, uttrakhand , India
Published Paper PDF: https://ijnrd.org/papers/IJNRD2306448.pdf
Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2306448
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This work is licensed under a Creative Commons Attribution 4.0 International License and The Open Definition
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