PMFLIST Archives

November 1998

PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Proportional 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:
Tony & Roz Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Sun, 1 Nov 1998 11:26:14 -0500
Content-Type:
text/plain
Parts/Attachments:
text/plain (21 lines)
The PDA Technical Report on the Validation of Aseptic Processing continued
to advocate a simple 0.1% contamination rate as a Media Fill criterion
despite the EU GMP Annex on Sterile products requiring a 95% confidence limit.

My question is whether US pharmaceuticals company are or have moved to use
of a confidence internal and whether they are using 1 in 4500 or 2 6300 is
the acceptance criterion?

Tony Cundell
Wyeth-Ayerst
[log in to unmask]


------------------
The PMFList (http://microbiol.org/pmf.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