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November 2019

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Subject:
From:
Robert Ryan <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 8 Nov 2019 08:55:36 +0000
Content-Type:
text/plain
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Ganesh,

What you are saying is your alert and action levels are set by you and are set in stone until your review and in relation to the results you have generated. In fact your action and alert levels, which I'd imagine you have calculations for each week on a spread sheet are constantly changing. Your argument is contradictory, as changes to your action limit are driven by the quality of your water and the frequency of their activation should always be roughly the same.

If you have good water your limits should be set tighter to generate roughly 5-10% alert.
If your water is susceptible to contamination or poorly managed you should have measures in place to control this and corrective actions to address those issues, however your action limit should still be set to generate roughly 5-10% alerts.

If you create something like action and alert levels you should be in control of what it is telling you. Your responses to the results should be documented and the ability to change them (either by increasing or decreasing) should occur based on the results generated after each round of testing and something that is reviewed on a regular basis.

The specification is a pharma requirement for the quality of your purified water. It is non-negotiable and cannot be changed.

In Summary, what are you doing when these figures are surpassed, will changing the figures impact on the quality of you water or processes involved.

Robert Ryan

Pharmaceutical Microbiologist


-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of ganesh chaudhari
Sent: 08 November 2019 03:47
To: [log in to unmask]
Subject: [PMFLIST] Purified water alert action limit setup.

Dear members,

I have query regarding alert and action limit of purified water.
If facility is having 3 tier limit system e.g. Alert level: 70 cfu/300 mL and Action level:100 cfu/mL, specification limit:100 cfu/mL.
During annual trend data review if alert limit found to be 15 cfu/300 mL and action. 33 cfu/300 mL as per 2 sigma and 3 sigma calculation, whether we need to change the limit or we can keep the same limit by giving rationale that purified water is having stringent limit hence existing limit will be considered for purified water.

Thanks
Ganesh

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