Newsletter | January 21, 2013

01.21.13 -- Guidance For Quality Systems Approach To cGMP Regulations

Bioresearch Online Newsletter

In This Issue:

Featured Articles

Guidance For Quality Systems Approach To cGMP Regulations
By Christine Park, Quality Architech
Why should pharmaceutical companies consider implementing a systemic approach to manufacturing and quality? The 21 CFR Parts 210 and 211 regulations provide direction for specific tasks and requirements to manufacture pharmaceutical products. But these regulations do not mandate integration of the activities or documentation of the interrelationship of these key processes to each other.


Decontamination: Hydrogen Peroxide Vapor (HPV) vs. Ultraviolet Radiation (UVC)
By Bioquell Inc.
The fundamental differences between these technologies, in terms of their mode of antimicrobial action and the method of delivery, result in a marked difference in microbiological impact. Bioquell HPV eradicates pathogens on hospital surfaces and achieves a 6-log sporicidal reduction in vitro.

The Right Place. The Right Time. At Just The Right Temperature.

The Right Place. The Right Time. At Just The Right Temperature.

Maintaining a controlled room temperature (CRT) during transport is more complex than it sounds. In this white paper, find out how UPS's unique temperature-sensitive services and global network make UPS the obvious choice for products that require safe, consistent temperature throughout the supply chain. Learn more.

Featured Downloads

Streamlining Particle Count Data Management: White Paper
Pharmaceutical cleanrooms have gone through drastic changes in recent years as mergers, acquisitions, facility closures, drug patent-cliffs, and other industry dynamics have forced manufacturing facilities to continually adapt to remain both competitive and compliant with U.S. Food and Drug Administration (FDA) regulations. 

Fast Quantification Of Salvia Samples In Microplates: Application Note
A successful evaluation study of saliva samples in microplates, using the Tecan Infinite F50 microplate reader in combination with the Tecan Magellan™ data analysis software and the Saliva Quantification Kit from Greiner Bio-One, for the fast detection of saliva samples.

Faster Time-To-Market: Case Study
In the past, numerous departments at P&G were part of the verification process. For example, artwork traveled through marketing, production, legal, regulatory, consumer relations, print production, product development, and creative services.

Quality In The Global Pharmaceutical Supply Chain: White Paper
Supplier quality has been a prime topic at recent industry conferences. Original equipment manufacturers (OEM), material suppliers, and contract manufacturers attended to listen to the implications and driving forces behind the scrutiny of our supply chain.

Metabolic Footprint Of Diabetes: A Multiplatform Metabolomics Study In An Epidemiological Setting
Metabolomics is the rapidly evolving field of the comprehensive measurement of ideally all endogenous metabolites in a biological fluid. However, no single analytic technique covers the entire spectrum of the human metabolome.
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Industry News

AstraZeneca Names New CEO

Designer Bacteria May Lead To Better Vaccines

Drugs For Diabetes: Scientists Test The Power Of Plants

GE Healthcare Files Supplemental NDA For Manufacturing Of Optison

FluCide Drug Candidates Significantly Superior To Tamiflu In Animal Studies Against H3N2 And H1N1 Viruses

DSM, Amgen Ink Deal For Use Of DSM's XD® Cell Culture Patents

3D Mapping Of Lipid Orientation In Biological Tissues Such As Skin

Scientists Find A New Way To Boost Common Cancer Drugs

Patheon Forms "Patheon Certified Consultants" Service

Scientists Seek Out Cancer Cells Hiding From Treatment
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Featured Products And Services

microRNA
microRNA

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Agilent Technologies

Synergy H1 Hybrid Multimode Microplate Reader
Synergy H1 Hybrid Multimode Microplate Reader

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BioTek Instruments, Inc.

Multimode Microplate Reader: Infinite® 200 PRO NanoQuant
Multimode Microplate Reader: Infinite® 200 PRO NanoQuant

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Tecan

UV-Vis Spectrophotometers: NanoDrop 2000/2000c
UV-Vis Spectrophotometers: NanoDrop 2000/2000c

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Thermo Scientific NanoDrop Products

Medical Device Integration With eCOA Solution
Medical Device Integration With eCOA Solution

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CRF Health

Anti GFP, Monoclonal Antibodies
Anti GFP, Monoclonal Antibodies

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Wako Laboratory Chemicals

Drug Safety Evaluation
Drug Safety Evaluation

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MPI Research

Serum-Free And Chemically Defined Media: IS CHO-CD4™
Serum-Free And Chemically Defined Media: IS CHO-CD4™

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Irvine Scientific

Mycoplasma Testing Services Listing
Mycoplasma Testing Services Listing

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Bionique Testing Laboratories, Inc.

Analytical Development And Testing
Analytical Development And Testing

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Therapure Biopharma Inc.

VHP M1000-T4 Biodecontamination System
VHP M1000-T4 Biodecontamination System

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STERIS Corporation

Crimping System
Crimping System

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ILC Dover