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New cGMP Analytical Services Laboratory Helps Customers Ensure FDA Compliance

Pharmaceutical manufacturers benefit from quality control contract services

 

Pittsburgh, Aug. 22, 2011—ASPEX Corporation (ASPEX) is expanding its business opportunities and is now a provider of contract analytical services according to current Good Manufacturing Practices (cGMP) as outlined by the Food and Drug Administration (FDA) .  ASPEX’s new Quality Management System is compliant with cGMP guidelines and enables pharmaceutical companies to design, improve and validate their products and processes through ASPEX unique blend of scanning electron and energy dispersive x-ray microscopy (SEM/EDX) hardware, software and reporting technology. This integrated spectroscopy allows customers to rapidly and automatically detect, identify, quantify and characterize the discrete features of an entire sample. ASPEX does this through both contract services as well as direct sales of its various product platforms, including the EXplore, the EXtreme and the EXpress.

 “Process and quality control in pharmaceutical manufacturing is not only critical for profitability, they are also essential in ensuring safety,” said Marie Vicéns, Ph.D., Manager, Analytic Services, ASPEX. “By establishing and following cGMP specifications as part of ASPEX analytical contract services, ASPEX can help drug companies rapidly, accurately, and clearly identify and analyze foreign particles as small as 0.1 microns in their product streams. This not only helps them comply with FDA regulations, but also helps maintain their reputation for quality and gives them a true competitive advantage.”


The new Quality Management System is a result of a year’s work including the addition of a new laboratory, finished in January 2011 after several months of planning and construction. The development also involved ASPEX manufacturing a lab-specific EXplorer platform and procuring other equipment dedicated to meeting certification and calibration requirements. Since opening the new facility at the end of April, ASPEX put together a team of scientists and quality assurance experts dedicated to conduct laboratory activities following strict quality guidelines including International Organization for Standardization (ISO 9001:2008) and Quality by Design (QbD). In that time, ASPEX has conducted the necessary internal audits to declare cGMP compliance and has continued to update and write more than 40 work instruction and standard operating procedure documents to build and improve the recently implemented Quality System.

            “While the majority of ASPEX business derives from the sales and service of various ASPEX solutions,” said Vicéns, “a significant portion also comes from customers who contract with us to conduct testing on their behalf. Often it’s the case that these contract customers, upon seeing the value that our systems can deliver in terms of automated and rapid detection, identification and characterization of defects and contaminants in a sample, end up purchasing a system for themselves.”

ASPEX is now inviting external audits from potential customers interested in working with a leading provider of integrated particle identification and characterization solutions. Such audits offer a no-cost, no obligation inspection of the company’s new quality practices, ensuring the culture of open, structured communication in delivering quality contract services ASPEX promises their current and future customers.

Pharmaceutical companies interested in auditing ASPEX’s offering are encouraged to contact Dr. Marie Vicéns at mvicens@aspexcorp.com or 1.724.468.5400 ext. 266.

 

 

For more information on ASPEX cGMP Compliant Pharmaceutical Services, click HERE.

 

EDITORIAL NOTE

 

If members of the news media would like to interview Dr. Vicéns or any of the subject matter experts and executive leadership of ASPEX Corporation, please contact:

 

Paul O’Rourke

Pipitone Group

(412) 321-0879

porourke@pipitonegroup.com.



ASPEX Corporation, headquartered in Pittsburgh, Pa., is a leading provider of integrated microanalysis, providing customers the unprecedented ability to rapidly and automatically detect, identify, quantify and characterize the features of an entire sample, giving them optimal quality control, production capacity and profitability. In short, ASPEX gives their customers the Power to Perceive, turning data into information that customers can use to maximize quality control efforts and bottom-line profitability. For more information on ASPEX visit www.aspexcorp.com.
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