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December 2003


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Laura Valdes-Mora <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Mon, 22 Dec 2003 12:41:10 EST
text/plain (54 lines)

I have replied to you twice but had problems getting the message through 
since Nov. 25.  

I think the fact the we are in different parts of the world make our 
realities very different.  We cannot take it down a few notches here in the USA.  Over 
here, most people will have to revalidate for 2 reasons:

1. To cover the new growth times of 3 days for bacteria and 5 days for fungi
2. To ensure the minimum amount of product volume is validated.

On the second one many people with SVPs will have to process more volume.  
This triggers revalidation.  Those with LVPs will process less, if they want to 
per the new table. If you chose to process entire contents, you do not have to 

I remember very clearly Terry Munson at the USP/PDA meeting last year stating 
that harmonization will trigger revalidation.  Terry was right, as usual.


Laura Valdes-Mora, MS
Technical Services Director
Elite MicroSource Corporation
3166 Wood Valley Road
Panama City, FL 32405
Phone: 850-763-5453
Fax: 850-913-9735
e-mail: [log in to unmask]
" Elite MicroSource is a training center for pharmaceutical microbiology 
providing seminars, video conferences, books, audits and Pharmaceutical Encounter 
Conferences."    Visit us at WWW.ELITEMICROSOURCE.COM

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