Navigation Links
Pharmaceutical Manufacturing Quality: Optimizing Your Internal Process for FDA Compliance
Date:10/19/2007

CHAPEL HILL, N.C., Oct. 19 /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 complimentary excerpt is available at http://www3.best-in-class.com/rr867.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

Quality man
'/>"/>

SOURCE Best Practices, LLC
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. South Africa Wins landmark case against pharmaceutical giants
2. Pharmaceutical giant offers AIDS related antifungal drug free to 50 countries
3. Pharmaceutical giant offers AIDS related antifungal drug free to 50 countries
4. Setting up a new pharmaceutical industry in India
5. Medicis Pharmaceutical company enters pediatric market
6. Supply of Radiopharmaceuticals Hampered by Attacks
7. Pharmaceutical companies are targeting patients
8. FDA approves Watson Pharmaceuticals Oxytrol patch
9. Ranbaxy Pharmaceuticals Inc awarded the prestigious outstanding supplier award received from Wal-Mart
10. Indian Pharmaceutical Industries Stops Manufacturing And Sale Of Valdecoxib
11. Pharmaceutical industries grant for R&D to be monitored
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/1/2014)... 2014 Woodland Hills dental ... group of dental specialists who treat full mouth implant ... of Oviedo. Dr. Reshad of the Anacapa Dental Art ... on two continents, will give a full-day presentation Oct. ... reconstruction. , “These specialists want to improve their skills ...
(Date:10/1/2014)... (PRWEB) October 01, 2014 Generic drug ... retail generics increasing in price in the last 12 ... Inc.’s (AIS) Drug Benefit News (DBN) interviewed a plan ... means for pharmacies and health plans. , “When ... rising generic acquisition costs, these cost increases squeeze pharmacies’ ...
(Date:10/1/2014)... insulin is safer and more effective than intermediate-acting ... to new research published in the BMJ ... twice-daily doses of both long- and intermediate-acting insulin, ... "In patients with Type 1 diabetes, we found ... when it came to controlling blood sugar, preventing ...
(Date:10/1/2014)... Looking for holiday gift ideas? Éminence Organic Skin ... giving easy this holiday season. Starting October 1st 2014, new ... all shopping dilemmas. Choose from two luxury skin care gift ... delicate eye area or to deliver whole body beauty. ... Duo Gift Set are formulated to suit all skin types ...
(Date:10/1/2014)... 01, 2014 To help raise awareness about ... Cutler Integrative Medicine, is detailing several tips for women looking ... According to Dr. Cutler, women should start each day with ... yourself that will help ‘center’ yourself for the rest of ... says. , Other health and fitness tips include:, -Drink ...
Breaking Medicine News(10 mins):Health News:Woodland Hills Dental Implants Expert Training Dental Specialists in Spain Later This Week 2Health News:Woodland Hills Dental Implants Expert Training Dental Specialists in Spain Later This Week 3Health News:Woodland Hills Dental Implants Expert Training Dental Specialists in Spain Later This Week 4Health News:Rising Generic Drug Prices Affect Pharmacies, Insurers Alike, Reports AIS Newsletter 2Health News:Rising Generic Drug Prices Affect Pharmacies, Insurers Alike, Reports AIS Newsletter 3Health News:Long-acting insulin is safer, more effective for patients with Type 1 diabetes 2Health News:Éminence Organic Skin Care Launches Limited Edition Spa Gift Sets for the Holiday Season 2Health News:Éminence Organic Skin Care Launches Limited Edition Spa Gift Sets for the Holiday Season 3Health News:In Recognition of National Women’s Health and Fitness Day, Cutler Integrative Medicine Details Tips for Living a Healthier and Happier Life 2
... routinely discarded placenta //might be a good source of stem ... of the journal Stem Cells. ,Researchers had found that ... of the amniotic sac have cells that are very similar ... two genes that make the embryonic stem cells unique in ...
... Researchers from Douglas Hospital Research Center in Montreal showed ... to deal with stressful situations than those who bottle-feed ... well established, this is for the first time findings ... as well. Researchers feel that this is good for ...
... 2005. Hormone Replacement Therapy (HRT) is commonly advocated in ... with increased chances of breast cancer and recently anxiety has ... Medical Journal// the cumulative risk of such a cancer developing ... as was previously reported. ,A team from New ...
... days when drinking was considered to be forbidden. It has ... ,A new research has found that drinking is not all ... reported to have better verbal skills, memory and speed of ... Moderate drinkers not only performed the best but also seemed ...
... wet hair may be far more effective treatment of ... used single blind randomized controlled trial for comparing the ... against head lice in United Kingdom. , ,Fine ... current over the counter chemical treatments for eliminating head ...
... The Food and Drug Administration FDA has recently ... prescription drug advertisements. ,The FDA and the ... practices for drugs, with agency research showing that ... benefits and do not adequately disclose risks. FDA's ...
Cached Medicine News:Health News:Researchers Gather Stem Cells From Discarded Placenta 2Health News:Breastfeeding Lowers Maternal Stress 2Health News:Risk of Breast Cancer Overestimated with Hormone Replacement Therapy(HRT) Treatment 2Health News:Yet Another Reason To Celebrate Drinking 2Health News:Combing Hair More Effective Than OTC Medicine For Head Lice 2
(Date:9/30/2014)... , Sept. 30, 2014  Wrightington, Wigan ... Allscripts (NASDAQ: MDRX ) are delighted to ... as WWL,s new health information system. The system will ... completely transform the way WWL delivers healthcare in the ... a demonstrated record of on-time and on-budget system implementations ...
(Date:9/30/2014)... 30, 2014 This study provides an ... informatics solutions including nuclear imaging informatics, PET imaging ... study assesses the size of the market based ... and projects future growth based on the current ... taking place in the broader markets for imaging ...
(Date:9/30/2014)... , Sept. 30, 2014  Decision Resources Group ... in Brazil , Russia ... China (BRIC) will see robust expansion ... increasingly favored over surgical procedures. Although revenues will be ... reimbursement challenges, prolonged device approval times and demand for ...
Breaking Medicine Technology:Wrightington, Wigan and Leigh NHS Foundation Trust selects Allscripts Sunrise 2Wrightington, Wigan and Leigh NHS Foundation Trust selects Allscripts Sunrise 3Wrightington, Wigan and Leigh NHS Foundation Trust selects Allscripts Sunrise 4Analysis of the US Molecular Imaging Informatics Market 2Analysis of the US Molecular Imaging Informatics Market 3Brazilian, Russian, Indian and Chinese Markets for Peripheral Vascular Devices Will See Strong Expansion Through 2023 2Brazilian, Russian, Indian and Chinese Markets for Peripheral Vascular Devices Will See Strong Expansion Through 2023 3
... Feb. 23, 2011 Roche (SIX: RO, ROG; OTCQX: RHHBY) ... Department of Defense (DOD) to provide remote service and support ... the DOD,s secure B2B gateway. Roche is the first in-vitro ... for this remote access. The B2B gateway is ...
... Feb. 23, 2011 Xenogenics Corporation ("Xenogenics"), a majority ... MCET), is pleased to announce it has retained the ... of its capital formation strategy to help finance expanded ... In animal testing and initial human use, the ...
Cached Medicine Technology:Roche Teams with Womack Army Medical Center to Become First IVD Manufacturer approved for Remote Network Connectivity with DOD 2Xenogenics Corporation Retains the Emmes Group to Advise on Fund Raising Efforts 2Xenogenics Corporation Retains the Emmes Group to Advise on Fund Raising Efforts 3Xenogenics Corporation Retains the Emmes Group to Advise on Fund Raising Efforts 4
Portable shields for your safety and convenience....
Provide 1.5mm protection throughout. Six durable, attractive vinyl coverings are available. Lead glass window factory installed. Larger window available....
Swing-Arm™ Scatter Shield® provides lower extremity protection for personnel close to the tube. 24"Wx32"L lead shield swings 180 along table. Ideal for cardiac cath, special studies, electr...
Front Protection with attached Belt Guard, Built-in Back Support; Buckle Closure...
Medicine Products: