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

Supplier quality management: Monitor...

Osani, John Eric.

Linked to FindBook

Google Book

Amazon

博客來

Supplier quality management: Monitoring the quality and compliance of API suppliers, defining Generic Pharma as the customer.

Record Type:	Language materials, printed : Monograph/item
Title/Author:	Supplier quality management: Monitoring the quality and compliance of API suppliers, defining Generic Pharma as the customer./
Author:	Osani, John Eric.
Description:	168 p.
Notes:	Source: Masters Abstracts International, Volume: 48-05, page: 2689.
Contained By:	Masters Abstracts International48-05.
Subject:	Business Administration, Management. -
Online resource:	http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=1484868
ISBN:	9781124024585

Supplier quality management: Monitoring the quality and compliance of API suppliers, defining Generic Pharma as the customer.
Osani, John Eric.

Supplier quality management: Monitoring the quality and compliance of API suppliers, defining Generic Pharma as the customer. - 168 p.

Source: Masters Abstracts International, Volume: 48-05, page: 2689.

Thesis (M.S.)--California State University, Dominguez Hills, 2010.

This thesis presents the theory of applying a detailed internal company system, Supplier Quality Management (SQM), which not only establishes, but monitors the quality and compliance of Active Pharmaceutical Ingredient (API) suppliers under the appropriate regulations and guidances. The Generic Pharmaceutical Industry is defined as the customer. The product is defined as the finished pharmaceutical drug product for use by the consumer.

ISBN: 9781124024585Subjects--Topical Terms:

626628
Business Administration, Management.

Supplier quality management: Monitoring the quality and compliance of API suppliers, defining Generic Pharma as the customer.
LDR:02037nam 2200313 4500 001 1401688
005 20111017084430.5
008 130515s2010 ||||||||||||||||| ||eng d
020 $a 9781124024585
035 $a (UMI)AAI1484868
035 $a AAI1484868
040 $a UMI $c UMI
100 1 $a Osani, John Eric. $3 1680839
245 1 0 $a Supplier quality management: Monitoring the quality and compliance of API suppliers, defining Generic Pharma as the customer.
300 $a 168 p.
500 $a Source: Masters Abstracts International, Volume: 48-05, page: 2689.
500 $a Adviser: Mike Falk.
502 $a Thesis (M.S.)--California State University, Dominguez Hills, 2010.
520 $a This thesis presents the theory of applying a detailed internal company system, Supplier Quality Management (SQM), which not only establishes, but monitors the quality and compliance of Active Pharmaceutical Ingredient (API) suppliers under the appropriate regulations and guidances. The Generic Pharmaceutical Industry is defined as the customer. The product is defined as the finished pharmaceutical drug product for use by the consumer.
520 $a There are no real strict regulations, or guidances, from the FDA, whereby 21CFR Parts 210 and 211 are loosely applied, unless the API manufacturer states they comply with these regulations, on this subject. Rather FDA and Generic Pharma utilize ICH Q7: cGMPs for API Manufacturing, among other pertinent ICH guidances.
520 $a The evolution of the concept of establishing supplier quality, especially a Supplier Quality Management (SQM) system, is examined to understand its intent in drug product formulation, protecting the drug consumer, the current expectations of pharmaceutical manufacturers, and the cost of non-compliance.
590 $a School code: 0582.
650 4 $a Business Administration, Management. $3 626628
650 4 $a Health Sciences, Pharmacy. $3 1017737
650 4 $a Education, Business. $3 1017515
690 $a 0454
690 $a 0572
690 $a 0688
710 2 $a California State University, Dominguez Hills. $3 1017917
773 0 $t Masters Abstracts International $g 48-05.
790 1 0 $a Falk, Mike, $e advisor
790 $a 0582
791 $a M.S.
792 $a 2010
856 4 0 $u http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=1484868