Lawrence X Yu1. 1. Food and Drug Administration, Office of Generic Drugs, 7519 Standish Place, Rockville, Maryland 20855, USA. Lawrence.Yu@fda.hhs.gov [corrected]
Abstract
PURPOSE: The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) and describe how it can be used to ensure pharmaceutical quality. MATERIALS AND METHODS: The QbD was described and some of its elements identified. Process parameters and quality attributes were identified for each unit operation during manufacture of solid oral dosage forms. The use of QbD was contrasted with the evaluation of product quality by testing alone. RESULTS: The QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include: Defining 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. CONCLUSIONS: Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. Product testing confirms the product quality. Implementation of QbD will enable transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment.
PURPOSE: The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) and describe how it can be used to ensure pharmaceutical quality. MATERIALS AND METHODS: The QbD was described and some of its elements identified. Process parameters and quality attributes were identified for each unit operation during manufacture of solid oral dosage forms. The use of QbD was contrasted with the evaluation of product quality by testing alone. RESULTS: The QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include: Defining 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. CONCLUSIONS: Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. Product testing confirms the product quality. Implementation of QbD will enable transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment.
Authors: Lawrence X Yu; Gordon L Amidon; James E Polli; Hong Zhao; Mehul U Mehta; Dale P Conner; Vinod P Shah; Lawrence J Lesko; Mei-Ling Chen; Vincent H L Lee; Ajaz S Hussain Journal: Pharm Res Date: 2002-07 Impact factor: 4.200
Authors: James E Polli; Lawrence X Yu; Jack A Cook; Gordon L Amidon; Ronald T Borchardt; Beth A Burnside; Philip S Burton; Mei-Ling Chen; Dale P Conner; Patrick J Faustino; Amale A Hawi; Ajaz S Hussain; Hemant N Joshi; Gloria Kwei; Vincent H L Lee; Lawrence J Lesko; Robert A Lipper; Alice E Loper; Shriniwas G Nerurkar; Joseph W Polli; Dilip R Sanvordeker; Rajneesh Taneja; Ramana S Uppoor; Chandra S Vattikonda; Ian Wilding; Guohua Zhang Journal: J Pharm Sci Date: 2004-06 Impact factor: 3.534
Authors: Andre S Raw; M Scott Furness; Devinder S Gill; Richard C Adams; Frank O Holcombe; Lawrence X Yu Journal: Adv Drug Deliv Rev Date: 2004-02-23 Impact factor: 15.470
Authors: Lawrence X Yu; Robert A Lionberger; Andre S Raw; Rosario D'Costa; Huiquan Wu; Ajaz S Hussain Journal: Adv Drug Deliv Rev Date: 2004-02-23 Impact factor: 15.470
Authors: James E Polli; Jack A Cook; Barbara M Davit; Paul A Dickinson; Domenick Argenti; Nancy Barbour; Alfredo García-Arieta; Jean-Marie Geoffroy; Kerry Hartauer; Shoufeng Li; Amitava Mitra; Francis X Muller; Vivek Purohit; Manuel Sanchez-Felix; John W Skoug; Kin Tang Journal: AAPS J Date: 2012-06-09 Impact factor: 4.009
Authors: Venkat Koganti; Fred Carroll; Richard Ferraina; Rick Falk; Yogesh Waghmare; Mark Berry; Yang Liu; Kenneth Norris; Robert Leasure; Jeffrey Gaudio Journal: AAPS PharmSciTech Date: 2010-10-28 Impact factor: 3.246
Authors: James E Polli; Bertil S I Abrahamsson; Lawrence X Yu; Gordon L Amidon; John M Baldoni; Jack A Cook; Paul Fackler; Kerry Hartauer; Gordon Johnston; Steve L Krill; Robert A Lipper; Waseem A Malick; Vinod P Shah; Duxin Sun; Helen N Winkle; Yunhui Wu; Hua Zhang Journal: AAPS J Date: 2008-08-05 Impact factor: 4.009