Rapid Methods - Influence of FDA's Strategic Plan for advancing Regulatory Science

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. Part 3 of this chapter says:

Reduce risk of microbial contamination of products:

  • Develop sensitive, rapid, high-throughput methods to detect, identify, and enumerate microbial contaminants and validate their utility in assessing product sterility;
  • Develop and evaluate methods for microbial inactivation/removal from pharmaceutical products that are not amenable to conventional methods of sterilization;
  • Evaluate the impact of specific manufacturing processes on microbial contamination; and
  • Develop reference materials for use by industry and academia to evaluate and validate novel methods for detecting microbial contamination.

Please also read the complete Strategic Plan.

Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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