PMFLIST Archives

July 1999

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Subject:
From:
"Lee, Lucy" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Fri, 9 Jul 1999 08:48:54 -0400
Content-Type:
text/plain
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text/plain (58 lines)
It is our current practice to test only one lot for raw materials for I/E
unless otherwise requested by our client.  Three lots of finished goods are
routinely tested for a validation


Thank you
Lucy Lee (Hall Dive Location)
Microbiology Business Associate II
AAI - Microbiology
1206 North 23rd Street
Wilmington NC 28405
Phone: (910) 251-6754           SAME PHONE NUMBER
Fax:     (910) 763-5899         NEW FAX NUMBER AT HALL ST

> -----Original Message-----
> From: Jeff Werner [SMTP:[log in to unmask]]
> Sent: Thursday, July 08, 1999 6:47 PM
> To:   [log in to unmask]
> Subject:      [PMFLIST] Inhibition/Enhancement LAL testing for Raw
> materials
>
> Members:
>
> I was wondering what industry practice is for performing LAL validation
> testing for raw materials. The USP, EP, or FDA Guidelines are specific for
> finished product testing. Therefore, I am curious to know whether folks
> perform a compendial gel clot inhibition / enhancement test for raw
> materials, with 3 lots being tested for one LAL vendor and just 1 lot for
> a
> backup LAL vendor. If you also use a second method such as kinetic, do you
> also repeat the testing with another 3/1 lots? If you do not perform I/E
> testing on raw materials, do you rely on just the positive product
> control?
> If so, have you encountered any issues from inspectors during audits?
> Thanks in advance for any information.
>
> Regards,
>
> Jeff_Werner @biogen.com
> V-P, PMF
>
>
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