Navigation Links
Pharmaceutical Manufacturing Quality: Optimizing Your Internal Process for FDA Compliance
Date:9/7/2007

CHAPEL HILL, N.C., Sept. 7 /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/rr851.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:11/24/2009)..., NEWYORK,Nov.24/PRNewswire/--TheGuardianLife...tmutuallifeinsurersandaleadingproviderofemployeebe...thatthecompanywillcontinuetofollowitscurrentinsura...eguidelinesareconsistentwiththeAmericanCancerSocie...sformammographyscreenings. ,, Recently,TheU.S.P...
(Date:11/24/2009)..., BREWER,Maine,Nov.24/PRNewswire/--Thankstoan...ineHealthcareSystems(EMHS)andAnthemBlueCrossandBlu...Islecannow"visit"theirphysicianwithoutleavinghome....healthrelatedmessagesandquestionsandcommunicatevia...ditiontoschedulingappointments,checkingontestresul...
(Date:11/24/2009)... INDIANAPOLIS Involving family members of pediatr...s benefits both the family and the medical team, a...icine study. , Riley Hospital for Children, whe...mall number of hospitals nationwide routinely offe...y patients the opportunity to join their child,s m...
(Date:11/24/2009)... Leading plastic surgery e...ns (ASPS), are available to discuss the recently p... Arlington Heights, IL (Vocus) November 24, ...merican Society of Plastic Surgeons (ASPS), are av...surgery tax., , ,WHAT: Some of the nation’s...
(Date:11/24/2009)...ommunity-associated strains have increased sevenfo...HealthDay News) -- Strains of antibiotic-resistant...creasingly showing up among hospital outpatients, ...cted, new research says. , From 1999 to 2006, r...ence of outpatients with methicillin-resistant St...
Breaking Medicine News(10 mins):Health News:The Doctor Will See You Now. . .Online 2Health News:Involving family in medical rounds benefits both family and medical team 2Health News:Involving family in medical rounds benefits both family and medical team 3Health News:Involving family in medical rounds benefits both family and medical team 4Health News:Leading Plastic Surgery Experts Available to Discuss Proposed ,Cosmetic Surgery Tax 2Health News:MRSA Creeping Into Hospitals From the Outside 2Health News:MRSA Creeping Into Hospitals From the Outside 3
...m the Dutch Health Insurance System model, accordi...the December issue of the Journal of Health Polit...agement, policy and community health at The Univer...its possible lessons for the United States. , Th...
...llness rates, missed classes, study shows , ...tions reduce college students, risk of illness, re... a new study shows , Researchers at the VA Medical...f U.S. college and university students get the flu...
...e left untreated, depending on man,s age , ...of prostate cancer may prompt an understandable fe...array of options at their disposal for tackling th...s. In fact, a growing number of doctors say many p...
...s M. D. Anderson Cancer Center will hold the first...nference on December 6-7, to bring together intern...scientists. , Participants will present new clin...ing the conference, the new IBC International Cons...
...s out this week add to the body of research eviden...ed with increased risk of adverse mental health ef... in the British Journal of Psychiatry and the J...m.com/cgi-bin/prnh/20080930/FRCLOGO ) , , "T...
...nc.,(Nasdaq: HOLX ), a leading developer, manufa...l imaging systems and surgical products dedicated ...nounced that Jack Cumming,Chairman and Chief Execu...San Francisco, CA. , Interested parties are ...
Other Medicine News:Health News:UT public health policy expert says US can learn from Dutch universal healthcare coverage 2Health News:Flu Shots Worthwhile for College Students 2Health News:Treatment Options Are Many for Prostate Cancer 2Health News:Treatment Options Are Many for Prostate Cancer 3Health News:M. D. Anderson to hold first international conference on inflammatory breast cancer 2Health News:Hologic to Present at the J.P. Morgan 27th Annual Healthcare Conference 2
(Date:11/24/2009)....C.,Nov.24/PRNewswire/--PharmaceuticalInstitute,al...pharmaceuticalandbiotechindustry,todayannouncedthe...henew HospitalMarketplace e-courseisthenewestaddit...ies,acomprehensiveseriesofe-coursesdesignedtofillt...wledgeforcommercialprofessionals. ,, Thenewthre...
(Date:11/24/2009)...ITY,Nov.24/PRNewswire/-- InfiniteMind ,aSaltLakeCi...inevisiontherapyprogrameyeQ,thesoftwareprogramisto...hods. ,, eyeQ wasintroducedattheCOVDconference...t,Dr.BradHabermehlbelievesthe eyeQ programaddssign...lintMichigan.Itallowshispatientstoembedpracticesfr...
(Date:11/24/2009)...N,Nov.24/PRNewswire-USNewswire/--America,spharmace...7medicinesandvaccinestotreatorpreventHIV/AIDSandre...bythePharmaceuticalResearchandManufacturersofAmeri...AIDSDay"-aglobalawarenesscampaignthatoriginatedatt...rAIDSPrevention. ,, "Wearegreatlyencouragedbyth...
Breaking Medicine Technology:Pharmaceutical Institute Launches New Training Resource Focused on the Hospital Marketplace 2Infinite Mind Announces the Launch of a New Online Vision Therapy Program eyeQ 2New Report Shows 97 Medicines and Vaccines Currently in Development for HIV/AIDS 2New Report Shows 97 Medicines and Vaccines Currently in Development for HIV/AIDS 3Statement by Jim OHara Director Produce Safety Project in Response to the FDAs Announcement Regarding Guidance on Produce Safety 53357 1Plastic Surgery Technique Might Ease Migraines 53354 1Plastic Surgery Technique Might Ease Migraines 53354 2Plastic Surgery Technique Might Ease Migraines 53354 3Webinar on 26quot 3BPhysician Engagement Diagnosing Generational Differences 26quot 3B Presented by Morehead Associates 53352 1Webinar on 26quot 3BPhysician Engagement Diagnosing Generational Differences 26quot 3B Presented by Morehead Associates 53352 2Webinar on 26quot 3BPhysician Engagement Diagnosing Generational Differences 26quot 3B Presented by Morehead Associates 53352 3
...ompleted a dual listing. The Company,s shares are ...addition to the OTC BB (OTC Bulletin Board: PLMO)....e in the future development and financing of the C...stors outside of the United States and Canada" - G...Tech,s operational subsidiary, PulmoScience, is pl...
... Inc. today announced that it is initiating a Phas...kappa opioid agonist, CR845. The Phase II multi-ce...be conducted in the United States and will evaluat... CR845 during the post-operative period in women f...rial is expected to enroll 120 patients, who will ...
Other Medicine Technology:Pulmo BioTech Inc. Announces Dual Listing on Frankfurt Borse 2Pulmo BioTech Inc. Announces Dual Listing on Frankfurt Borse 3Cara Therapeutics Initiates Phase II Proof-Of-Concept Trial of Novel Analgesic in Acute Post-Operative Pain 2
HydroExpression Cannula - Corydon
Hydrodissector - Pearce
Irrigating Cystotome
Lasik Irrigator - 4 ports
Medicine Products: