PMFLIST Archives

April 2000

PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Subject:
From:
steve richter <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Tue, 25 Apr 2000 10:06:14 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (79 lines)
Tina,

I agree with Tony.  The laboratory should be qualified with preparatory
testing on the products.    We recommending qualify the laboratory with
check samples..  Samples that are spiked with organisms and samples that are
sterile...

Steven Richter Ph.D.
President and Scientific Director
Microtest Labs, Inc
8006311680
[log in to unmask]
www.microtestlabs.com


-----Original Message-----
From: Anthony Cundell <[log in to unmask]>
To: [log in to unmask] <[log in to unmask]>
Date: Monday, April 24, 2000 11:42 PM
Subject: Re: [PMFLIST] Comparative Testing


Tina,

Since almost all the products to be tested will the transferred ML Test
contain no bioburden we decided to get the receiving lab to repeat some
elements of the preparatory testing to qualify the test.

Tony Cundell
Wyeth-Ayerst Pharmaceuticals

>>> Tina Kramer <[log in to unmask]> 04/20 11:50 AM >>>
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


------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) as a service to
the scientific community.


------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) as a service to
the scientific community.


------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) as a service to
the scientific community.



ATOM RSS1 RSS2