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:12/9/2016)... ... December 09, 2016 , ... The Justin Veatch Fund ... (NCADD) is recommending the film Whispering Spirits and its discussion guide ... Columbia as an education tool in the war against teen drug abuse. NCADD ...
(Date:12/9/2016)... , ... December 09, 2016 , ... ... at The Pierre Hotel in New York, NY, on December 3rd, to benefit ... and physicians attended the annual event, which raised over $1 million - the ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... Quality Insights beginning January 1, 2017. The name change aligns the entire ... measuring and improving health care quality. , “We are very proud of the ...
(Date:12/8/2016)... Islandia, NY (PRWEB) , ... December 08, 2016 ... ... company, is pleased to announce that “Natural Language Processing–Enabled and Conventional Data Capture ... published in JMIR Medical Informatics . , Results of the comparative usability ...
(Date:12/8/2016)... ... ... With the increasing demand for dental implants, the National Association of Dental Laboratories ... and patients about the safety issues related to dental restorations. According to the American ... projected to reach $6.4 billion in 2018 with more than 30 million Americans missing ...
Breaking Medicine News(10 mins):
(Date:12/8/2016)... -- Research and Markets has announced the addition of the ... ... report analyzes the worldwide markets for Endodontic Supplies in US$ Thousand. The report ... Japan , Europe , Asia-Pacific ... Annual estimates and forecasts are provided for the period 2015 through 2022. Also, ...
(Date:12/8/2016)... Dec. 8, 2016 Bodycad announced it ... improving the accuracy, reproducibility and speed for 3D ... and small bone orthopaedic applications. These patents are ... personalized orthopaedic restorations based on each patient,s distinct ... the company harnesses the world,s first suite of ...
(Date:12/8/2016)... Texas , Dec. 8, 2016 ... program that brings leading-edge laboratory services and management ... United States , allowing more doctors and ... health care management solutions. Logo - ... Hospital systems, under pressure to contain ...
Breaking Medicine Technology: