Alert limits in trend analysis of a water system

GOOD VALIDATION PRACTICE (cGVP)
1

Dear Friends,

I am responsible for performing the trend analysis for the manitoring of water systems in my facility.

Every year, we have to define an alert limit for the water systems (Water For Injection loop, Purified Water loop, Pure Steam loop), according to the precedent year results.
The action limit (that leads to an OOS) is the max value permitted given in the pharmacopeia.
The alert limit is just that, to alert responsibles on values increase.

What is you approach to define an alert limit. ¿Is there any regulation that specifies how to define an alert level?

Thanks for your kind help

2

After completion of validation study, based on the analysis data, validation team members should prepare detailed report, which recommends the sampling procedure, sampling conditions, Alert & Action limits (based on the data max count will be taken as alert limit,) & sampling schedule for the seasonal variations for the next rest of months.

3

Alert and Action should be defined based on the data of Phase - I validaiton.

Alert Limit: Average + 2 X Standard Deviation
Action Limit: Average + 3 X Standard Deviation

This is a Statistical calculation, to calculate the alert & action limits, followed by most of the regulatory approved Pharmaceutical firms.

4

[quote=vamsemicro]Alert and Action should be defined based on the data of Phase - I validaiton.

Alert Limit: Average + 2 X Standard Deviation
Action Limit: Average + 3 X Standard Deviation

This is a Statistical calculation, to calculate the alert & action limits, followed by most of the regulatory approved Pharmaceutical firms.[/quote]

Dear sir, is this specified in any guideline???

5

guideline about alert and action limits of water system in WHO- TRS 970 2012 page 85

“Monitoring data should be subject to trend analysis (trending should
typically be within 2 sigma). Suitable alert and action levels should be established
based on historical reported data”

sigma in here is standard deviation

6

During validation of the water system while performing the PQ, collect the data. Validation of water system has to be carried out for seasonal variation also. After collection of data you can set the alert limit after observing the results and their trends. There is no rule as such for setting alert limit. It may vary from company to company, water system to water system. The data collected during the validation should be evaluated for setting the alert limit.
Dr.Pradeep Nagalkar,
Head Quality Control
Haffkine Bio-Pharma. Corp. Ltd.
Mumbai