Yes---  THE EMPEROR HAS NO CLOTHES- published studies show the methods in 
general do not have the capabilities many of us wish that they did. 
However, the methods are the methods. Specifications/requirements are tied 

to the methods (or should be). We (the pharmaceutical industry) are 
required to have adequate control over microorganisms in our respective 
products. If the user does not believe that they have adequate control 
they should do something to achieve what they would consider adequate 
control. There are provisions for using alternative methods (USP <1223>). 
It should not be hard to show that a "good method" is equal to or better 
than a "bad" method in detecting microbial contaminants. i.e the good 
method picks up everything the bad method does and then some. There is no 
method that will pick up every single contaminant or potential 
contaminant. As has been pointed out repeatedly, paradigms have worked 
their way into many guidelines and regulations. This took time. It will 
take time to get them out.The more published information "out there" 
preferably in refereed journals the more ammunition regulators and 
industry have to work with. As we all know, it can take very little effort 

to get a paradigm into a guideline, regulation or SOP but the proverbial 
"act of God" to get it out. This is now the era of scientific proof for 
methods and specifications- this proof works both directions i.e it 
(method) works or it does not work. Unfortunately,saying something does 
not work is not proof and cannot be acted upon.

The usual disclaimer- I speak for myself.

Kirby

J. Kirby Farrington, Ph.D. (RM/SM) NRM
Specialist Microbiologist-ASCP
Research Advisor-Microbiology and Sterility Assurance
Eli Lilly  Indianapolis  46285
Lilly LTC   Mail Stop 5546
317-651-9620  Beep.256-2840 cell 317-430-6548

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