東華大學圖書館 |

Language: English

Help

回圖書館首頁

手機版館藏查詢

Back

Switch To: Labeled | MARC Mode | ISBD

Quality by Design (QbD) and Producti...

Blackburn, Timothy D.

Linked to FindBook

Google Book

Amazon

博客來

Quality by Design (QbD) and Production System Fundamental Sigma Limits with a Pharmaceutical Industry Example.

Record Type:	Language materials, printed : Monograph/item
Title/Author:	Quality by Design (QbD) and Production System Fundamental Sigma Limits with a Pharmaceutical Industry Example./
Author:	Blackburn, Timothy D.
Description:	302 p.
Notes:	Source: Dissertation Abstracts International, Volume: 73-02, Section: B, page: .
Contained By:	Dissertation Abstracts International73-02B.
Subject:	Engineering, System Science. -
Online resource:	http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=3478998
ISBN:	9781124970561

Quality by Design (QbD) and Production System Fundamental Sigma Limits with a Pharmaceutical Industry Example.
Blackburn, Timothy D.

Quality by Design (QbD) and Production System Fundamental Sigma Limits with a Pharmaceutical Industry Example. - 302 p.

Source: Dissertation Abstracts International, Volume: 73-02, Section: B, page: .

Thesis (Ph.D.)--The George Washington University, 2012.

Quality by Design (QbD) has been recognized as a superior manufacturing approach versus attempting to test in quality. Without designing for quality, the level of quality attainment (defect-free product) has been observed to plateau well short of six sigma, and efforts to further improve quality are met with diminishing returns on investment. This research quantitatively evaluates the phenomenon of a manufacturing sigma wall or quality plateau in the context of technological evolution, and demonstrates that QbD is superior to a quality by testing-centric model.

ISBN: 9781124970561Subjects--Topical Terms:

1018128
Engineering, System Science.

Quality by Design (QbD) and Production System Fundamental Sigma Limits with a Pharmaceutical Industry Example.
LDR:02985nam 2200337 4500 001 1405805
005 20111214135010.5
008 130515s2012 ||||||||||||||||| ||eng d
020 $a 9781124970561
035 $a (UMI)AAI3478998
035 $a AAI3478998
040 $a UMI $c UMI
100 1 $a Blackburn, Timothy D. $3 1685223
245 1 0 $a Quality by Design (QbD) and Production System Fundamental Sigma Limits with a Pharmaceutical Industry Example.
300 $a 302 p.
500 $a Source: Dissertation Abstracts International, Volume: 73-02, Section: B, page: .
500 $a Advisers: Thomas A. Mazzuchi; Shahram Sarkani.
502 $a Thesis (Ph.D.)--The George Washington University, 2012.
520 $a Quality by Design (QbD) has been recognized as a superior manufacturing approach versus attempting to test in quality. Without designing for quality, the level of quality attainment (defect-free product) has been observed to plateau well short of six sigma, and efforts to further improve quality are met with diminishing returns on investment. This research quantitatively evaluates the phenomenon of a manufacturing sigma wall or quality plateau in the context of technological evolution, and demonstrates that QbD is superior to a quality by testing-centric model.
520 $a The pharmaceutical industry, in which QbD is emerging as a recommended practice, is used as an example and case study in the research. Pharmaceutical development and manufacturing systems also rely on a Quality by Testing (QbT) model that uses release testing and other measures for assurance of quality. However, there is a significant gap between typical pharmaceutical production system capability (&sim; 2.5--3.5 sigma) and supplied quality (&sim; 5.16--5.6 sigma). To sustain high levels of product supply quality, the industry incurs a high cost of quality while retaining value at risk.
520 $a The research confirms the gap between shipped pharmaceutical quality and production sigma. It also identifies systems-characteristic behavior (specifically the S-Curve technological evolution profile) that supports the use of systems theory and improvement tools. Finally, it performs a trade study to evaluate the extent to which QbD elements as expressed in contemporary literature eliminate production system contradictions (i.e. conflicts or unresolved trade-offs) needed to move to higher S-Curves and performance in comparison to the traditional model. The research also recommends additional QbD elements to minimize the effects of system contradictions.
590 $a School code: 0075.
650 4 $a Engineering, System Science. $3 1018128
690 $a 0790
710 2 $a The George Washington University. $b Engineering Mgt and Systems Engineering. $3 1028210
773 0 $t Dissertation Abstracts International $g 73-02B.
790 1 0 $a Mazzuchi, Thomas A., $e advisor
790 1 0 $a Sarkani, Shahram, $e advisor
790 1 0 $a Murphree, E. Lile $e committee member
790 1 0 $a Holzer, Thomas H. $e committee member
790 1 0 $a Eveleigh, Timothy $e committee member
790 $a 0075
791 $a Ph.D.
792 $a 2012
856 4 0 $u http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=3478998