Navigation Links
Six Critical Areas to Ensure Regulatory Compliance in Aseptic Manufacturing are Outlined in New Management Brief
Date:7/31/2012

AGAWAM, Mass., July 31, 2012 /PRNewswire/ -- An unscheduled inspection of an aseptic manufacturing process can hit a pharmaceutical company with the fury of a New England nor'easter. But a new management brief explains how a best-practice control and monitoring system can minimize the danger of FDA noncompliance. The brief is available for download from http://www.microtestlabs.com/weathering-the-storm-brief.

In the aseptic manufacturing business, all processes must be best practice to ensure the process will comply with the regulations. If any are poorly designed, not utilized, or deviated from, then the entire aseptic manufacturing system is considered out of compliance. This means that the checks and balances of a quality system must ensure that the sterile environments and surrounding support SOPs truly are working and show no signs of trending towards failure.

The new management brief, "Weathering the Storm of Regulatory Compliance in Aseptic Manufacturing," outlines six critical areas that should be addressed to avoid the possibility of product contamination:

  • Training and professional development
  • Environmental monitoring (EM) procedures
  • Incorporation of single-use technology (e.g. needle/tubing sets)
  • Facility design and maintenance
  • Process simulation
  • Raw material control, preparation, and sterilization

"The FDA has been very critical of aseptic fill/finish companies whose manufacturing environments are out of trend or outside of specifications," noted management brief author Alexander (Alex) Mello, M.S., SM (NRCM), the director of Project Management, Manufacturing at Microtest Laboratories, Inc., in Agawam, MA.

"Rigorous production system control and monitoring through data genera
'/>"/>

SOURCE Microtest Laboratories
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Survey Shows eContent Critical to Corporate Strategies
2. PharMEDium Highlights Enhanced Labeling for ICU Services at Critical Care Expo
3. Hamamatsus NanoZoomer whole-slide scanners play a critical role in CSHLs Mouse Brain Architecture Project
4. PendoTECH Single Use Process Sensors Reduce The Environmental Impact Of Critical Bioprocess Operations
5. Bath Salts: With Dangerous Drug Use on the Rise, Ameritox Launches Critical New Test to Help Detect Designer Drug
6. Pulse Oximetry Screening Hailed as the New Milestone to Combat Critical Congenital Heart Disease - Signal Extraction Technology Leading the Way in Large, Independent Clinical Studies
7. Government Affairs Groups Play Critical Role in Protecting Organizations in Turbulent Times
8. PAREXEL Launches The PAREXEL BioPharm Unit To Meet The Critical Development Goals Of Small And Mid-Sized Biopharmaceutical Companies
9. KALO Announces Distribution Areas
10. Providers of Durable Medical Equipment Ensure Independence and Safety during Extreme Weather and Power Outages
11. Sensitech Inc. Products Receive Regulatory Compliance Approval from IATA
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/20/2014)... Calif. , Aug. 20, 2014 The National ... Fernando Davila has been successfully treated for a ... by Dr, Anibal R. Gauto , Medical Director of ... at Eisenhower Medical Center in Rancho Mirage, California ... treatment pioneered by Dr. John Crew at Seton ...
(Date:8/20/2014)... , Aug. 20, 2014 Research and ... Report of Pralmorelin" report to their offering. ... providing comprehensive data on Pralmorelin globally and regionally ( ... North America , Latin America ... Pralmorelin This report focuses on three primary areas; ...
(Date:8/20/2014)... DUBLIN , Aug. 20, 2014 ... addition of the "Global Advanced Wound Care ... Geography) - Size, Share, Global Trends, Company Profiles, ... Forecast, 2013 - 2020" report to their ... "Global advanced wound care and closure market (types, ...
Breaking Medicine Technology:Rancho Mirage, California Physician Saves Casino Worker from Deadly 'Flesh Eating Disease' 2Rancho Mirage, California Physician Saves Casino Worker from Deadly 'Flesh Eating Disease' 3Rancho Mirage, California Physician Saves Casino Worker from Deadly 'Flesh Eating Disease' 4Rancho Mirage, California Physician Saves Casino Worker from Deadly 'Flesh Eating Disease' 5Rancho Mirage, California Physician Saves Casino Worker from Deadly 'Flesh Eating Disease' 6Global Market Report of Pralmorelin 2Global Advanced Wound Care and Closure Market (Types, Applications, End User and Geography) - Forecast to 2020 2
... 2011 3-V Biosciences, Inc. announced today Stephen R. Brady ... (Logo:   http://photos.prnewswire.com/prnh/20100513/LA04336LOGO ) "Steve,s contributions have been ... at 3-V," said Merdad V. Parsey, MD, PhD, 3-V,s Chief ... we continue to build the 3-V team and advance the ...
... 2011 Awarepoint Corporation today announced it conducted its ... and User Group , Viewpoint | 2011, January 23-25, ... http://photos.prnewswire.com/prnh/20100127/LA44915LOGO ) At this exclusive Awarepoint event, ... with other hospitals to share information and use cases ...
Cached Medicine Technology:3-V Biosciences Promotes Stephen R. Brady to Chief Business Officer 2Awarepoint Announces First Annual RTLS Customer Conference and User Group Results and Highlights 2Awarepoint Announces First Annual RTLS Customer Conference and User Group Results and Highlights 3Awarepoint Announces First Annual RTLS Customer Conference and User Group Results and Highlights 4
(Date:8/20/2014)... 20, 2014 A common approach to treating kidney ... not improve survival chances for people who suddenly developed ... the University of Pittsburgh School of Medicine. , Their ... , suggest acute hemodialysis, an aggressive method that is ... not provide a definitive benefit to the patient. , ...
(Date:8/20/2014)... (August 20, 2014) Research from Columbia University Medical ... in stomach cancer growth and that blocking nerve signals ... treatment for the disease. The study was conducted by ... with Duan Chen, MD, PhD, in Norway and is ... . , "Scientists have long observed that human and ...
(Date:8/20/2014)... 20, 2014 The non-small cell lung ... in the offing across the top 8 developed nations, ... to around USD 8 billion by 2020-end, posting a ... is projected to be driven by innovative therapies entering ... lacking efficient treatment, unlike the non-squamous segment. Thus, patients ...
(Date:8/20/2014)... Rosa, CA (PRWEB) August 20, 2014 The ... the 12 per diode panel band perfect spectrum that encompasses ... are most likely to use during photosynthesis. A key ... bands is that they almost exclusively reside between 440-480 on ... on the red side of the spectrum. The KIND LED ...
(Date:8/20/2014)... MI (PRWEB) August 20, 2014 In its ... drug and alcohol treatment program that gets clients off to ... recovery they can believe in, is highlighting an important and ... be heeded by everyone who wants to understand the insidious ... are of the belief that drug abuse targets a certain ...
Breaking Medicine News(10 mins):Health News:Pitt analysis questions use of acute hemodialysis treatment 2Health News:Severing nerves may shrink stomach cancers: Botox injections slow growth of tumors in mice 2Health News:Top 8 Developed Nations NSCLC Market to Grow at CAGR of 6.6% Through 2020, Says GBI Research in Its Report Published at MarketPublishers.com 2Health News:Top 8 Developed Nations NSCLC Market to Grow at CAGR of 6.6% Through 2020, Says GBI Research in Its Report Published at MarketPublishers.com 3Health News:Top 8 Developed Nations NSCLC Market to Grow at CAGR of 6.6% Through 2020, Says GBI Research in Its Report Published at MarketPublishers.com 4Health News:Cheap LED Grow Lights Are Quickly Being Replaced by Premium Grow Lights 2Health News:New A Forever Recovery Blog Post Reminds People that Drug Abuse Doesn’t Discriminate 2Health News:New A Forever Recovery Blog Post Reminds People that Drug Abuse Doesn’t Discriminate 3
... Oct. 20 Strong new pledges of,commitment ... donors, government,officials, corporations, foundations and non-governmental organizations,today ... Deliver conference, which,sought to mobilize political will ... worldwide. More than 1,800 participants from ...
... YORK, Oct. 20 EmPower Research, LLC, a ... Consulting, launched its,first-ever study on the Indian Contract ... titled ,Indian Contract Research Industry, (CRO-nicles),captures the industry,s ... to the top line industry executives first hand. ...
... Following is a statement,by Linda A. Suydam, D.P.A., ... the recommendations issued today by the U.S.,Food and ... Committee. At a meeting this week, the joint ... medicines in children., "For decades, parents and ...
... Court, WILMINGTON, Del., Oct. 19 The following,statement ... W.Va., zinc,smelter class action lawsuit. The statement is to ... "We are extremely disappointed by the outcome of the ... unfairly punished for doing,the right thing for this property ...
... Mass., Oct. 19 LeMaitre Vascular,Inc. (Nasdaq: ... and implants for the treatment of peripheral vascular ... Annual Healthcare Conference on,Tuesday, November 6, 2007, in ... George W. LeMaitre, Chairman and Chief Executive Officer, ...
... the less the idea bothered her , , FRIDAY, Oct. ... the idea of childlessness than men, new research shows, ... how each gender views the pressures of parenthood. , ... and parenthood mean different things," said study author Tanya ...
Cached Medicine News:Health News:Women Deliver Conference Launches New Commitments 2Health News:EmPower Research Launches Indian CRO Industry Report 2Health News:Statement from the Consumer Healthcare Products Association on Today's Joint FDA Advisory Committee Recommendations Regarding Pediatric Over-the-Counter Cough and Cold Medicines 2Health News:DuPont Responds to Spelter, W.Va., Lawsuit Decision 2Health News:Childlessness Bothers Men More Than Women 2Health News:Childlessness Bothers Men More Than Women 3
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: