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FDA Aseptic Inspections Will Focus on Process, FDA’s Friedman Says
Published March 27, 2014
At a PDA conference track at Interphex 2014, FDA’s Richard Friedman, Associate DirectorAssociate Director of FDA’s Office of Manufacturing and Product Quality at the Center for Drug Evaluation and Research’s Office of Compliance, discussed changes in the way FDA inspectors will review aseptic facilities. The emphasis now, he says, will be on day to day process operations and control. Read More »
Grand River Aseptic Manufacturing
By Val Dittrich, Marketing Coordinator
Grand River Aseptic Manufacturing is a parenteral contract manufacturer providing small scale clinical trial materials aseptically filled into vials and lyophilization for the pharmaceutical and biopharmaceutical markets. In addition to sterile manuf… Read More »
Aseptic Validation in Single-Use Technology
By Richard Bhella and Vishwas Pethe, ATMI LifeSciences
Published April 3, 2013
A new testing process may improve results Read More »
Aseptic Processing Validation
By Ross Acucena and Randy Wilkins
Published April 4, 2012
Best practices for sterile filtration validation of re-use and extended-use processes Read More »
Published February 27, 2012
A method of producing a sterile (devoid of living organisms) product in which sterile bulk drug or raw materials are compounded and assembled with sterile packaging components.… Read More »
Single-use Disposable Systems for Aseptic Fill/Finish
By Robert L. Roy, PE
Published June 6, 2011
Today’s disposable systems offer improved manufacturing efficiency, and better QA and regulatory compliance — and they can be the fastest route to media fills Read More »
Aseptic Processing Update
By Hal Baseman
Published April 5, 2011
What�s new in aseptic processing, validation, and contract manufacturing? Read More »
Complex Aseptic Manufacturing Outsourcing
By Carlos R. Fernandez and Douglas A. Jonas
Published April 1, 2009
Tips and tactics for optimizing your CMO partnership Read More »
Aseptic Process Validation
By Tom Spurgeon
Published November 3, 2006
Is a new FDA guidance imminent? Read More »
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