Dear members,
Thank you for prompt response.
Did it means that we can use historical data to set alert level and action ,
and would not be a set of SPECIFICATION from any regulation ?
Thank you very much.
Regards,
Fc Lim
-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
<[log in to unmask]> On Behalf Of Marc Glogovsky
Sent: Wednesday, 10 May, 2023 9:33 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] specification of settled plate of non sterile solid
dosage manufacturing
In a non-sterile facility you would use a risk-based approach (including
historical/trend EM data) to establish an appropriate alert & action level.
You would use these metrics to ensure that you are in a state of control.
I would point you towards USP <1115> as well as the current FDA draft
guidance on Microbiological Quality Considerations for non-sterile drug
manufacturing (https://www.fda.gov/media/152527/download).
Of course, take a look at as many of the reference articles in both
aforementioned documents as they all offer great supporting information.
Sincerely,
Marc Glogovsky, MS, S.M. (NRCM)
Business Unit Manager - Microbiology Consulting
609.432.1314
valsource.com<https://www.valsource.com/>
From: The Pharmaceutical Microbiology Forum Email List
<[log in to unmask]> on behalf of Lim Foong Choo
<[log in to unmask]>
Date: Wednesday, May 10, 2023 at 9:03 AM
To: [log in to unmask]
<[log in to unmask]>
Subject: [PMFLIST] specification of settled plate of non sterile solid
dosage manufacturing Dear PMF members,
What is the specification of settled plate (cfu/plate/4 hours) specification
of non-sterile manufacturing facility ?
Shall I know the references ?
Regards,
Lim
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