Navigation Links
Pharma Manufacturing Quality: Optimizing Processes for FDA Compliance
Date:4/18/2008

CHAPEL HILL, N.C., April 18 /PRNewswire/ -- With safety issues making headlines, pharmaceutical and medical device manufacturers face a rugged regulatory landscape. Organizations are relying on their quality function to navigate regulatory difficulties that could affect production. Proper staffing of quality roles is just one way organizations optimize their quality function and a study by pharmaceutical benchmarking leader Best Practices, LLC found best-in-class companies have a ratio of quality personnel to total manufacturing employees between 1:4 and 1:7.

As captured in the benchmarking report, The Quality Function: Structure, Staffing and Execution, Best Practices, LLC, reveals strategic best practices in quality harnessed from survey responses and in-depth interviews with seven top pharmaceutical and medical device company leaders. A complementary excerpt is available at http://www3.best-in-class.com/rr930.htm .

Executives from Abbott, Lilly, J&J, GlaxoSmithKline, Wyeth and others shared wisdom and key insights for honing elite quality functions within their organizations. A sampling of their tactics and best practices includes:
* Heighten intra- and inter-company transparency: Disseminate

information about weak areas within the company and competitor

companies among quality staff, as reflected in regulatory consent

decrees and warning letters obtained from FDC publications and

Gold/Green/Pink Sheets.

* Establish action-triggering metrics: Develop reporting mechanisms that

bring performance measurements and deviation reports before the eyes of

senior management.

* Focus quality personnel on activities/results not measures: Employ

integrated improvement charts to effectively communicate important

measures to focus actions by responsible parties. E.g., 3-in-1 charts

To find out more about Best Practices Research and Consulting, please visit our website at http://www.best-in-class.com or contact Grant Houston at 919-767-9182 or ghouston@best-in-class.com.

ABOUT BEST PRACTICES, LLC

Best Practices, LLC is a research and consulting firm that conducts work based on the principle that organizations can chart a course to superior economic performance by studying the best business practices, operating tactics and winning strategies of world-class companies. For more information, call (919) 403-0251 or visit http://www3.best-in-class.com/.


'/>"/>
SOURCE Best Practices, LLC
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Anemia and tropical diseases; Is pharmacogenomics ready for the clinic?
2. Mylan Commences Tender Offers and Consent Solicitations for Its 5.750% Senior Notes Due 2010 and 6.375% Senior Notes Due 2015 in Connection With Its Proposed Acquisition of Mercks Generic Pharmaceutical Business
3. Arena Pharmaceuticals to Present at the NewsMakers in the Biotech Industry Conference
4. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
5. The Pharma & Life Sciences Best Practice Database: an Industry Resource for Successful Techniques and Performance Benchmarks for Reaching the Top
6. Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet
7. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Adipex-P(R)
8. National Pharmaceutical Council Announces New Strategic Focus, Search for New Leadership
9. AKELA Pharma Inc. announces positive results for the extension part of its Phase IIb Fentanyl TAIFUN(R) trial
10. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Coreg(R)
11. Innocoll Agrees the Sale of its CollaRx(R) GENTAMICIN SURGICAL IMPLANT and European Sales and Marketing Infrastructure to EUSA Pharma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/25/2017)... ... 25, 2017 , ... Centurion Service Group welcomes ... Manager for the Northeast and Florida regions. In this role, Jennifer will build ... assets. , Jennifer joins Centurion with a wealth of knowledge and expertise, bringing ...
(Date:7/25/2017)... Irving, Texas (PRWEB) , ... July 25, 2017 ... ... and fastest growing ATM provider in the United States, today announced its partnership ... to financial institutions. , The foundation of the solution lies within Hyosung’s ...
(Date:7/24/2017)... ... 24, 2017 , ... Engineers at the University of Maryland have invented an ... of electrical energy that the body uses. , In ordinary batteries the electrical ... electrons out of the battery is generated by moving positive ions from one end ...
(Date:7/24/2017)... , ... July 24, 2017 , ... ... federal Substance Abuse and Mental Health Services Administration’s (SAMHSA) State Targeted Response to ... Department of Health Care Services, will facilitate the development of a hub and ...
(Date:7/24/2017)... (PRWEB) , ... July 24, 2017 , ... Every year, ... invigorating and educational conference, InstructureCon. Each annual event is coupled with a dynamic theme ... with a James Bond theme, Mission: InstructureCon 0017. , To extend their partnership ...
Breaking Medicine News(10 mins):
(Date:7/17/2017)... , July 17, 2017  MedX Holdings, Inc., ... medical testing, strengthening and rehabilitation equipment, today announced the ... Program. MedX is considered the gold standard for the ... in specialized medical strengthening equipment. ... lease with the physician or practice who prescribe the ...
(Date:7/14/2017)... LAS VEGAS , July 13, 2017 It ... the United States is in the midst of ... Disease Control , since 1999, the number of overdose deaths ... , "resulting in over half a million dead from 2001 ... like codeine, oxycodone, and hydrocodone has similarly quadrupled, drawing a ...
(Date:7/13/2017)... Md. , July 13, 2017  New York City-based ... of pharmaceutical markets should be aware of.  From new products ... trends are detailed in a recently completed study, Potential ... 1.  Age-Driven Growth ... we have been aware of the impact the growing population ...
Breaking Medicine Technology: