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• Mikrobiologische News zu Schnellmethoden

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  Axel Henning Schroeder    Premium Member   Group moderator

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  Mikrobiologische News zu Schnellmethoden

  1. FDA Strategic Plan and Rapid Methods
  
  The increasing importance of Rapid Microbiological Methods was shown by the activities of European and US authorities. The replacement of conventional methods by alternative methods is more and more accepted as a way to amend control of the product quality and further consumers safety.
  
  The FDA's Strategic Plan of August 2011 "Advancing Regulatory Science at FDA" addresses in chapter 2 "Support of New Approaches to Improve Product Manufacturing and Quality " amongst others the implementation of Rapid Microbiological Methods.
  more details:
  http://www.gmp-compliance.org/eca_news_02760_x.html
  
  
  2. Faster Sterility Tests for Biological Products
  
  The FDA Center for Biologics Evaluation and Research (CBER) in Rockville, MD, published a poster that considers rapid sterility testing and compares different modern methods with compendial methods. Seema Parveen, Simleen Kaur, James L. Kenney, William M. McCormick and Rajesh K. Gupta, researchers in the Division of Product Quality (DPQ) in the Office of Compliance and Biologics Quality (OCBQ) are working to reduce the expenditure of time for classic sterility testing by evaluating rapid microbial methods for sterility testing of biologicals.
  
  The alternative methods they evaluated are:
  
  BACTEC
  
  BacT/ALERT R
  
  Rapid MilliflexR
  
  more details:
  http://www.gmp-compliance.org/eca_news_02761_x.html
  
  
  3. Representatives of the FDA and EDQM will give in December information about the current activities of the authorities like Revision of EP<5.1.6>
  http://www.rmm-conference.org/mse_RMM_Home_x.html
  
  • 13 Sep 2011, 2:33 pm
  Axel Henning Schroeder wrote: > 1. FDA Strategic Plan and Rapid Methods > > The increasing importance of Rapid Microbiological Methods was shown > by the activities of European and US authorities. The replacement of > conventional methods by alternative methods is more and more > accepted as a way to amend control of the product quality and further > consumers safety. > > The FDA's Strategic Plan of August 2011 "Advancing Regulatory Science > at FDA" addresses in chapter 2 "Support of New Approaches to Improve > Product Manufacturing and Quality " amongst others the implementation > of Rapid Microbiological Methods. > more details: > http://www.gmp-compliance.org/eca_news_02760_x.html > > > 2. Faster Sterility Tests for Biological Products > > The FDA Center for Biologics Evaluation and Research (CBER) in > Rockville, MD, published a poster that considers rapid sterility > testing and compares different modern methods with compendial > methods. Seema Parveen, Simleen Kaur, James L. Kenney, William M. > McCormick and Rajesh K. Gupta, researchers in the Division of Product > Quality (DPQ) in the Office of Compliance and Biologics Quality > (OCBQ) are working to reduce the expenditure of time for classic > sterility testing by evaluating rapid microbial methods for sterility > testing of biologicals. > > The alternative methods they evaluated are: > > BACTEC > > BacT/ALERT R > > Rapid MilliflexR > > more details: > http://www.gmp-compliance.org/eca_news_02761_x.html > > > 3. Representatives of the FDA and EDQM will give in December > information about the current activities of the authorities like > Revision of EP<5.1.6> > http://www.rmm-conference.org/mse_RMM_Home_x.html