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
e-mail: [log in to unmask]
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