UGC Approved Journal no 63975

ISSN: 2349-5162 | ESTD Year : 2014
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Published in:

Volume 6 Issue 6
June-2019
eISSN: 2349-5162

UGC and ISSN approved 7.95 impact factor UGC Approved Journal no 63975

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Published Paper ID:
JETIR1908A73


Registration ID:
227274

Page Number

853-861

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Title

QUALITY BY DESIGN APPROACH (QBD) FOR PHARMACEUTICALS: A REVIEW

Authors

Abstract

Quality by Design is the modern approach for quality of pharmaceuticals. It describes use of Quality by Design to ensure quality of Pharmaceuticals. In this review, the Quality by Design is described and some of its elements 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. It is based on the ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, Q10 for pharmaceutical quality systems. It also gives application of Quality by Design in pharmaceutical development and manufacturing of pharmaceuticals. The aim of the pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. Quality cannot be tested into products but quality should be built in by design. It includes the Quality target product profile, critical quality attributes and key aspects of Quality by Design. It also gives comparison between product quality by end product testing and product quality by Quality by Design. The foundation of Quality by Design is ICH Guidelines.

Key Words

Quality by Design (QBD), Process Analytical Technology (PAT), Quality target product profile, Critical quality attributes.

Cite This Article

"QUALITY BY DESIGN APPROACH (QBD) FOR PHARMACEUTICALS: A REVIEW", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.6, Issue 6, page no.853-861, June 2019, Available :http://www.jetir.org/papers/JETIR1908A73.pdf

ISSN


2349-5162 | Impact Factor 7.95 Calculate by Google Scholar

An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 7.95 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator

Cite This Article

"QUALITY BY DESIGN APPROACH (QBD) FOR PHARMACEUTICALS: A REVIEW", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.6, Issue 6, page no. pp853-861, June 2019, Available at : http://www.jetir.org/papers/JETIR1908A73.pdf

Publication Details

Published Paper ID: JETIR1908A73
Registration ID: 227274
Published In: Volume 6 | Issue 6 | Year June-2019
DOI (Digital Object Identifier):
Page No: 853-861
Country: -, -, - .
Area: Engineering
ISSN Number: 2349-5162
Publisher: IJ Publication


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