EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

European Journal of Pharmaceutical and Medical Research (EJPMR) has indexed with various reputed international bodies like : Google Scholar , Indian Science Publications , InfoBase Index (In Process) , SOCOLAR, China , Research Bible, Fuchu, Tokyo. JAPAN , International Society for Research activity (ISRA) , Scientific Indexing Services (SIS) , Polish Scholarly Bibliography , Global Impact Factor (GIF) (Under Process) , Universal Impact Factor , International Scientific Indexing (ISI), UAE  , Index Copernicus , CAS (A Division of American Chemical Society) USA (Under Process) , Directory of Open Access Journal (DOAJ, Sweden, in process) , UDLedge Science Citation Index , CiteFactor , Directory Of Research Journal Indexing (DRJI) , Indian citation Index (ICI) , Journal Index (JI, Under Process) , Directory of abstract indexing for Journals (DAIJ) , Open Access Journals (Under Process) , Impact Factor Services For International Journals (IFSIJ) , Cosmos Impact Factor , Jour Informatics (Under Process) , Eurasian Scientific Journal Index (ESJI) , International Innovative Journal Impact Factor (IIJIF) , Science Library Index, Dubai, United Arab Emirates , Pubmed Database [NLM ID: 101669306] (Under Process) , IP Indexing (IP Value 2.40) , Web of Science Group (Under Process) , Directory of Research Journals Indexing , 

 ISSN 2394-3211

Impact Factor: 6.222

 ICV - 79.57

Abstract

QUALITY BY DESIGN (QBD): A MODERN APPROACH FOR DEVELOPMENT OF QUALITY PHARMACEUTICALS

*Kiran Bhaskar Kudande, Sachin Jalindar Fartade and Ravindra Babasaheb Gawand

ABSTRACT

Recently the concept of ―Quality by Design‖ (QbD) gaining much attention among pharmaceutical industries for maintaining Quality. It serves as a bridge between industry and drug regulatory authorities to move towards a scientific, risk based, holistic and proactive approach for development of pharmaceutical product. It mainly covers QbD elements include defining target product quality profile, designing product, Quality Risk Management, Design of Experiment, PAT, identifying critical quality attributes, process parameters & controlling manufacturing processes to produce consistent quality over time. Also Benefits, Steps involved in Quality by Design, pillars of QbD, Analytical QbD. It also gives application of Quality by Design in pharmaceutical development and manufacturing of pharmaceuticals. The purpose of this review is to discuss the concept of pharmaceutical Quality by Design and describe how it can be help to ensure pharmaceutical quality & drug development.

Keywords: Quality by Design, Quality Target Product Profile, Critical Quality Attributes, Critical Process Parameter, Process Analytical Techniques, Design of Experiment.


[Full Text Article]

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  • New Issue Published

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Google Scholar Indian Science Publications InfoBase Index (In Process) SOCOLAR, China Research Bible, Fuchu, Tokyo. JAPAN International Society for Research activity (ISRA) Scientific Indexing Services (SIS) Polish Scholarly Bibliography Global Impact Factor (GIF) (Under Process) Universal Impact Factor International Scientific Indexing (ISI), UAE Index Copernicus CAS (A Division of American Chemical Society) USA (Under Process) Directory of Open Access Journal (DOAJ, Sweden, in process) UDLedge Science Citation Index CiteFactor Directory Of Research Journal Indexing (DRJI) Indian citation Index (ICI) Journal Index (JI, Under Process) Directory of abstract indexing for Journals (DAIJ) Open Access Journals (Under Process) Impact Factor Services For International Journals (IFSIJ) Cosmos Impact Factor Jour Informatics (Under Process) Eurasian Scientific Journal Index (ESJI) International Innovative Journal Impact Factor (IIJIF) Science Library Index, Dubai, United Arab Emirates Pubmed Database [NLM ID: 101669306] (Under Process) IP Indexing (IP Value 2.40) Web of Science Group (Under Process) Directory of Research Journals Indexing