To effectively apply a Rapid Microbial Method (RMM) technique and leverage its value, the end user must match his or her application and requirements to the beneŽfits and performance of the RMM.
Understanding the general approach to validation as well as the inter-relationships between personnel and their qualiŽfications,guidance and regulations, statistics employed, test equipment, test protocols, and data analysis techniques enhances this evaluation. Through this holistic understanding, more robust dialogue can be fostered, and ultimately, a more successful adoption of an RMM technology may be realized.
Goals of Validation Architecture include:
• Delivers meaningful and relevant content to end user
• Can e ectively determine “that the performance characteristics of the RMM meet the requirements for the intended application, in comparison to the traditional method” (USP<1223>)
• Harmonizes statistical approach and methods that satisfy related guidelines (e.g. EP, ISO, TR33, JIS...)
• Methods and results withstand the rigor, scope, and neutrality expected by Regulators
To view an interesting poster on this subject (from BioVigilant Systems, Inc.), click here.
Posted by Tim Sandle
Understanding the general approach to validation as well as the inter-relationships between personnel and their qualiŽfications,guidance and regulations, statistics employed, test equipment, test protocols, and data analysis techniques enhances this evaluation. Through this holistic understanding, more robust dialogue can be fostered, and ultimately, a more successful adoption of an RMM technology may be realized.
Goals of Validation Architecture include:
• Delivers meaningful and relevant content to end user
• Can e ectively determine “that the performance characteristics of the RMM meet the requirements for the intended application, in comparison to the traditional method” (USP<1223>)
• Harmonizes statistical approach and methods that satisfy related guidelines (e.g. EP, ISO, TR33, JIS...)
• Methods and results withstand the rigor, scope, and neutrality expected by Regulators
To view an interesting poster on this subject (from BioVigilant Systems, Inc.), click here.
Posted by Tim Sandle
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