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April 2000


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Tina Kramer <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Thu, 20 Apr 2000 11:50:16 -0400
text/plain (25 lines)
For those of you who have been involved with the transfer of products from one
manufacturing and testing site to another via the PAC-ATLS (Postapproval
Changes--Analytical Testing Laboratory Sites) guidelines....have you performed
comparative testing for Microbial Limits Testing between the two laboratories
involved.  Is comparative testing necessary for the transfer of Microbial limit
methods?  If so, how have you determined acceptance criteria for the comparison?
For example, what if one lab recovers an organism that the other lab does not
recover, even if the presence of that organism does not result in an OOS result?
What if both labs get different, but passing total aerobic count results?  Due
to the variability and the fact that organisms may not be evenly distributed
throughout a batch, how do you determine how much variability would be
acceptable?  Any insight would be appreciated!

Tina Kramer
Teva Pharmaceuticals USA

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