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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 9 Jul 2020 07:55:31 +0200
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Dear Selena,

we also are a non-sterile CMO manufacturer.
We investigate every monitoring exceeding, if it is alert or action, by 
root-cause-analysis.
It is communicated to QA, manufacturing/packaging dept. & QP.
We may define actions, but we only have to for action level exceeding.
For 3 consecutive alert level exceedings, we act like action limit 
exceeded.

As to have a rationale for this, we defined the alert (calculated by 
historical data) & action (given by guideline) level as follows:
The alert level is the highest mark for a normal/routinely working process 
(manufacturing, cleaning & disinfection), exceedings do not mean, we would 
have a risk to product, but the process did not work properly.
The action limit, may - depending on the height and the type of testing 
(floor, ceilings, walls, personal, machines, etc.) - mean that there can 
be a risk to the product or a big fault in the process, which has to be 
clarified and CAPA defined for not undergoing such an event again.

With kind regards

i.A. Mario Schüngel
Manager Environmental Monitoring



Von:    Selena Rossi <[log in to unmask]>
An:     [log in to unmask]
Datum:  08.07.2020 16:17
Betreff:        Re: [PMFLIST] limit of allert and out of trend
Gesendet von:   The Pharmaceutical Microbiology Forum Email List 
<[log in to unmask]>



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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> Steris -
> 
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>
> Charles River Laboratories -
> 
https://protection.retarus.com/v1?u=https%3A%2F%2Fnam04.safelinks.protection.outlook.com%2F%3Furl%3Dhttps%253A%252F%252Fwww2.criver.com%252Fl%252F60962%252F2020-03-27%252Fh6jqv6%26amp%3Bdata%3D02%257C01%257Cmeckhardt%2540FORMULATEDSOLUTIONS.COM%257Ce126a220af49400d59dd08d819c5eb0d%257Cbb3a191583134114ade87268361e2953%257C1%257C0%257C637287685139229064%26amp%3Bsdata%3DYC8U6xKxV%252FZ3%252BgZsAEEjv8nGzwij46nsGAU6JXyNE08%253D%26amp%3Breserved%3D0&c=3ilYS6l&r=2wCpRZnVpD5uMLMRnUVMKk&k=7s1&s=Q2UEiBNJYBV3BoXAkc8es8iismN66JB8bAvpOjyjWsq

>
> Veltek Associates, Inc -
> 
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>
> Microbiologics, Inc. -
> 
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>
> BD Industrial Media -
> 
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>
> Associates of Cape Cod, Inc. -
> 
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>
>
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> Steris - 
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>
> Charles River Laboratories -
> 
https://protection.retarus.com/v1?u=https%3A%2F%2Fwww2.criver.com%2Fl%2F60962%2F2020-03-27%2Fh6jqv6&c=3ilYS6l&r=5RtnSdBidzHS0253KwCOaQ&k=7s1&s=1a06IpS5QSJtbPAxPtfqFarsXWGB4n1T5Y5JEqdCv96

>
> Veltek Associates, Inc - 
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>
> Microbiologics, Inc. - 
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>
> BD Industrial Media - 
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>
> Associates of Cape Cod, Inc. - 
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Steris - 
https://protection.retarus.com/v1?u=http%3A%2F%2Fwww.sterislifesciences.com%2F&c=3ilYS6l&r=2keD8oihnQDDHepC3pDpOi&k=7s1&s=cSbWH7DooYQZvQYdA83FOPHVRM4BOOdQQD3qjZtDII2


Charles River Laboratories - 
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Veltek Associates, Inc - 
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Microbiologics, Inc. - 
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BD Industrial Media - 
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Associates of Cape Cod, Inc. - 
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The nature of this service is to provide a medium for communication.  The 
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list.



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Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
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Steris - http://www.sterislifesciences.com/

Charles River Laboratories - https://www2.criver.com/l/60962/2020-03-27/h6jqv6

Veltek Associates, Inc - http://www.sterile.com

Microbiologics, Inc. - http://www.microbiologics.com

BD Industrial Media - http://www.bd.com/ds/

Associates of Cape Cod, Inc. - http://www.acciusa.com/


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The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of the PMF or the sponsors of the list.

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