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July 2020

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Subject:
From:
Robert Pritchett <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 8 Jul 2020 15:08:46 +0000
Content-Type:
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Selena,

You can use text from PDA TR13 Fundamentals of an Environmental Monitoring Program to support investigation after three consecutive results that exceed alert level:

"Three or more consecutive points or drifts may be considered to be a pattern or cluster formation that, if above the alert level, signals a trend that requires investigation."

Also, USP  <1231> for water systems mentions "Exceeding an Alert Level repeatedly" as something that should elevate to Action level status which should prompt "immediate notification of both QA staff and the personnel involved in water system operations and use".

-RP

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Selena Rossi (External)
Sent: Wednesday, July 08, 2020 5:50 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] limit of allert and out of trend

Thank you Maria! very helpful.

A question about the first/second exceeding in alert limit. Do you notify to other departure (QA, QP, manufacturer) the exceeding the alarm limit without preliminary investigation?
We want to perform investigation as OOS after three consecutive alert limit but the guideline are not clear about it, someone want investigation for alert and action, some other only for action limit.
For us a OOT is three consecutive exceeding in alert limit, not only one but I need more guidance to prove it and explain to audits.

Thanks for your help,
Selena



Il giorno ven 26 giu 2020 alle ore 19:37 Maria Eckhardt < [log in to unmask]> ha scritto:

> Hi Selena:
>
> I have always had treated 3 consecutive alert as an action limit. Just 
> like an action limit, three consecutive alerts will require 
> investigation an corrective actions (i.e. repairs, cleaning, 
> resampling, etc). The practice has been found to be acceptable thru 
> all my regulatory and customer audits as a non-sterile CMO manuf. Hope this helps.
>
> Maria
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List < 
> [log in to unmask]> On Behalf Of Selena Rossi
> Sent: Friday, June 26, 2020 4:15 AM
> To: [log in to unmask]
> Subject: [PMFLIST] limit of allert and out of trend
>
> Hi everybody,
> do you investigate any single breach of alert levels or 3 consecutive 
> breaches?
> I work in a non sterile manufacturing (oral solid) and we want to 
> review our procedure.
>
> Could you suggest any guidance about alert leve in enviromental and 
> how to manage OOT?
> What is your experience about it?
>
> Thanks in advance!
> Have a good day,
> Selena
>
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