Testing Featured Articles
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Implementing A Systemic Approach To Pharmaceutical Quality Systems
1/3/2013
In 2002, the Food and Drug Administration (FDA) announced an initiative to integrate quality systems and risk management approaches into existing regulations for pharmaceutical manufacturing. While the FDA hasn’t changed the 21 Code of Federal Regulations (CFR) Parts 210 and/or 211 regulations, they have published industry guidance, Quality Systems Approach to Pharmaceutical CGMP Regulations. By Christine Park, Quality Architech
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Rapid Mycoplasma Testing Service Delivers Speed, Sensitivity And Specificity To A Broad Scope Of Sample Matrices
10/17/2012
Mycoplasma are the smallest known self-replicating prokaryotes. They parasitize a wide range of host organisms, including humans, animals, plants and insects and are common contaminants of mammalian cell culture. By Dr. Jeri Ann Boose, director, Biopharmaceutical Services, and Dr. Weihong Wang, manager, Molecular & Cell Biology Services
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Quintiles Deepens Investment In China
6/18/2012
In a ceremony underscoring the growing importance of China to the global biopharmaceutical industry, Quintiles executives and local dignitaries recently announced agreements to establish a Quintiles regional headquarters for China in Shanghai and to significantly expand lab testing capabilities in China.
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Clean Room Environmental Best Practices For Medical Device And Pharmaceutical Manufacturers Are Focus Of Boston Seminar On June 6
5/30/2012
Sterile manufacturing environments at medical device and pharmaceutical companies require effective cleaning and disinfection programs to maintain aseptic conditions and prevent microbial contamination. To help, laboratory testing experts will present "Clean Room Environmental Best Practices," a special seminar in Boston on Wednesday, June 6, 2012.
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Covance-BML To Expand Clinical Trial Laboratory In Japan
4/26/2012
Covance Inc., a leading provider of drug development services, and BML, Inc., a leading Japanese laboratory testing company, recently announced the expansion of the Covance-BML Clinical Trial Laboratory (CB Trial Lab) in Kawagoe City, Saitama Prefecture to enhance the capacity and capabilities in the region.
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4 Steps To “Right Sizing” Your Personnel Resources To Support Quality
We all have them and we all need them. The real question is do you have the right resources? And, do you have enough to support your quality system? By Christine Park, Quality Architech
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Gaining Greater Predictability, Control And Quality In Bioprocessing With Metabolic Biomarkers
Biologics are an integral part of the landscape of current therapies as pipelines continue to fill with them. Due to their importance and this ever expanding pipeline, the demands continue to escalate due to cost pressure, competition, regulatory requirements, disposable systems, and biosimilars. To date, these demands arguably have primarily been met with empirical understanding. However, there is a critical need for new approaches, tools, and technologies to deliver deeper understanding beyond the empirical realm. By Dr. Kirk Beebe, Director of Application Science, Metabolon, Inc.