(75.101.220.230)
Users online: 3175    [ij] [ij] [ij] 
Email id
 

Asian Journal of Research in Pharmaceutical Science
Year : 2016, Volume : 6, Issue : 1
First page : ( 45) Last page : ( 50)
Print ISSN : 2231-5640. Online ISSN : 2231-5659.
Article DOI : 10.5958/2231-5659.2016.00007.2

Quality by Design

Chavan Sushila D.1,*, Pimpodkar Nayana V.2, Kadam Amruta S.1, Gaikwad Puja S.1

1Lecturer, College of Pharmacy (D. Pharm) Degaon, Satara, (MH), India-415 004

2Principal, College of Pharmacy (D. Pharm) Degaon, Satara, (MH), India-415 004

*Corresponding Author E-mail: sushiladchavan@gmail.com

Online published on 2 April, 2016.

Abstract

Quality by design (QbD) is an essential part of the modern advance to pharmaceutical quality. QbD is best key to build a quality in all pharmaceutical products. Under this concepts of Be throughout design and growth of product, it is important to identify desire product performance report [Target product profile (TPP), Quality Target product profile (QTPP)] and identify critical quality attributes (CQA). To recognize the impact of raw material [critical material attributes (CAM)], critical process parameters (CPP) on the CQAs and identification and control sources of changeability. The plan of pharmaceutical development is to design a quality products and its manufacturing process always deliver the future performance of the product. The base of Quality by design is ICH Guidelines Q8 for Pharmaceutical for development, Q9 quality risk management, Q10 for pharmaceutical quality systems.

Top

Keywords

QBD-Quality by Design.

Top

  
║ Site map ║ Privacy Policy ║ Copyright ║ Terms & Conditions ║ Page Rank Tool
447,045,074 visitor(s) since 30th May, 2005.
All rights reserved. Site designed and maintained by DIVA ENTERPRISES PVT. LTD..
Note: Please use Internet Explorer (6.0 or above). Some functionalities may not work in other browsers.