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INTERNATIONAL JOURNAL OF CREATIVE RESEARCH THOUGHTS - IJCRT (IJCRT.ORG)

International Peer Reviewed & Refereed Journals, Open Access Journal

IJCRT Peer-Reviewed (Refereed) Journal as Per New UGC Rules.

ISSN Approved Journal No: 2320-2882 | Impact factor: 7.97 | ESTD Year: 2013

Call For Paper - Volume 14 | Issue 3 | Month- March 2026

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  Published Paper Details:

  Paper Title

Quality By Design In Pharmacy

  Authors

  Rushikesh Gajanan Navale,  Dr.Harshal Anwane,  Dr. Shivshankar Mhaske,  Karan Dnyanba Gavhane,  Mayur Gulab Kharat, Rahul Ganesh Wankhade, Shankar Ramkrushn Bali And Om Nandkishor Bhandurge

  Keywords

Quality by Design, QTPP, CQAs, Design Space, Control Strategy, CMAs, CPPs, Risk Management.

  Abstract


In the pharmaceutical sector, Quality by Design (QbD) is a revolutionary strategy that emphasizes a proactive, scientifically grounded approach to guaranteeing product quality. Designing quality into the product from the very beginning of development is the main goal of QbD, in contrast to traditional approaches that depend on end-product testing. With the support of important regulatory agencies like the FDA and the International Council for Harmonization (ICH), this methodical approach guarantees adherence to strict quality requirements. In order to start the QbD process, a Quality Target Product Profile (QTPP) that outlines the performance criteria and desirable product attributes must be created. Critical Quality Attributes (CQAs) are the physical, chemical, biological, and microbiological characteristics that need to be managed to guarantee that the product fulfills the quality criteria that are intended. Critical Process Parameters (CPPs) and Critical Material Attributes (CMAs), which affect the CQAs, are identified in order to accomplish this control. QbD enables the development of a strong control strategy by utilizing sophisticated statistical tools, risk management strategies, and a deep comprehension of the manufacturing process. By reducing variability and guaranteeing constant product quality, this approach improves production processes, lowers the chance of batch failures, and reduces recalls. There are several advantages to using QbD into pharmaceutical development, such as increased overall efficiency, better product quality, and improved regulatory compliance. It supports the industry's transition to more creative, patient-centered methods, guaranteeing that the end result is not only the best in terms of quality but also safe and effective. In conclusion, Quality by Design is a progressive, all-encompassing strategy that alters the development and production of pharmaceutical goods by placing an emphasis on quality across the entire process.

  IJCRT's Publication Details

  Unique Identification Number - IJCRT2412828

  Paper ID - 274441

  Page Number(s) - h459-h481

  Pubished in - Volume 12 | Issue 12 | December 2024

  DOI (Digital Object Identifier) -   

  Publisher Name - IJCRT | www.ijcrt.org | ISSN : 2320-2882

  E-ISSN Number - 2320-2882

  Cite this article

  Rushikesh Gajanan Navale,  Dr.Harshal Anwane,  Dr. Shivshankar Mhaske,  Karan Dnyanba Gavhane,  Mayur Gulab Kharat, Rahul Ganesh Wankhade, Shankar Ramkrushn Bali And Om Nandkishor Bhandurge,   "Quality By Design In Pharmacy", International Journal of Creative Research Thoughts (IJCRT), ISSN:2320-2882, Volume.12, Issue 12, pp.h459-h481, December 2024, Available at :http://www.ijcrt.org/papers/IJCRT2412828.pdf

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Call For Paper March 2026
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ISSN and 7.97 Impact Factor Details


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ISSN: 2320-2882
Impact Factor: 7.97 and ISSN APPROVED
Journal Starting Year (ESTD) : 2013
ISSN
ISSN and 7.97 Impact Factor Details


ISSN
ISSN
ISSN: 2320-2882
Impact Factor: 7.97 and ISSN APPROVED
Journal Starting Year (ESTD) : 2013
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