The growth promotion and BF test results were both good.
We had a recall for a contaminated product and the FDA came in for a visit
shortly after.
It was an observation as I recall.
Paul Phillips
Quality Operations
Pfizer Inc
100 Pfizer Drive
Terre Haute, IN 47802
Phone: (812) 299-2121 EXT 269
Fax: (812) 299-6014
Email [log in to unmask]
-----Original Message-----
From: Gayle Shaw [mailto:[log in to unmask]]
Sent: Thursday, December 11, 2003 12:20 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] media fill using thioglycollate medium
The FDA observation did not care that the lot was growth promoted before
use to show that the media promotes growth? Is the positive test just a
recommendation?
Gayle Shaw
QE Validation Microbiologist
Cryolife, Inc
"Phillips, Paul" <[log in to unmask]>
Sent by: The Pharmaceutical Microbiology Forum Email List
<[log in to unmask]>
12/11/2003 09:34 AM
Please respond to The Pharmaceutical Microbiology Forum Email List
To: [log in to unmask]
cc:
Subject: Re: [PMFLIST] media fill using thioglycollate medium
I've always written Sterility test procedures to include at least one
daily
positive control for the media lots used.
I picked up this practice from an FDA observation back in 1991...
Paul Phillips
Quality Operations
Pfizer Inc
100 Pfizer Drive
Terre Haute, IN 47802
Phone: (812) 299-2121 EXT 269
Fax: (812) 299-6014
Email [log in to unmask]
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