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May 2001


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Scott Sutton <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Thu, 3 May 2001 12:48:46 GMT
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This is the problem with presenting information on ongoing projects.
This position fell through on further discussions when it became
apparent that there was no way to "grandfather" products.

You neglected to mention the year that slide was presented, I would
imagine that it is at least 3-4 years old as the recent history of the
harmonization effort in microbiology has not been nearly so hopeful.
It is difficult to come to common ground when one party to the process
repeatedly reverses agreements and insists that theirs is the only
valid position.

We may never see a fully harmonized PET or Sterility test, but at
least the last 6 years have brought the methods somewhat more in line.


On Wed, 2 May 2001 10:49:42 -0400, you wrote:

>Scott, thanks for your response.  The following is taken from a slide that
>you presented regarding review of microbial regulations/AET:
>        FDA must detail a mechanism for handling grandfathered products.
>        In the absence of protection, USP cannot agree to "regulate" safe
>and effective products off the market
>        In the presence of protection, USP is inclined to accept EP criteria
>The third point was somewhat concerning, but it sounds as though there is
>not a significant effort to harmonize the acceptance criteria.  Thanks again
>for your input.
>Art Faulkner
>-----Original Message-----
>From: Scott Sutton [mailto:[log in to unmask]]
>Sent: Tuesday, May 01, 2001 6:46 PM
>To: [log in to unmask]
>Subject: Re: [PMFLIST] PET criteria
>Okay, since no one else is going to touch this one I will answer it.
>The methods are "essentially harmonized."  The criteria may not be
>without some compromise on the European side (unlikely, as little or
>no desire to compromise has been evident to date from the European
>side).  The USP probably will not accept the more stringent EP
>criteria because there is no compelling reason to do so.  In other
>words, no one has been able to make a believable case that there is a
>problem with products on the US market that acceptance of the EP
>criteria would fix.
>In addition, if the USP were to move to more stringent requirements,
>then the FDA could well consider itself obligated to enforce these
>criteria against products currently on the US market.  Many of these
>products would not meet the more strigent expectations and might well
>be subject to recall.
>The USP is thought to be unwilling to regulate products off the market
>for no measureable gain in safety or efficacy.
>Scott Sutton
>On Tue, 24 Apr 2001 08:39:11 -0400, you wrote:
>>Can anyone provide an update on the harmonization of the preservative
>>efficacy test through PDG.  I understand that the test methods are
>>considered essentially harmonized, however the acceptance criteria are very
>>different.  I've heard that USP may consider adopting the more stringent
>>Eur. Criteria.  What is the current status of this proposal to harmonize
>>acceptance criteria?
>>Art Faulkner
>>The PMFList ( is operated from
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>The PMFList ( is operated from
>The Microbiology Network ( and supported by
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>The PMFList ( is operated from
>The Microbiology Network ( and supported by
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The PMFList ( is operated from
The Microbiology Network ( and supported by
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the scientific community.