Thursday, 22 December 2016

Alert and Action Limits


  • In pharmaceuticals alert and action limits are very important, because these limits are effective control to the process.
  • alert and action limits are in house limits, these limits must be less than guideline limits or define limits.
  • Alert and action limits defined based on trend analysis.
  • alert and action limits are like a barrier before the guideline limits.
Alert Limit:
  • To be alert the microbial counts reach to this alert level.
  • It is nor necessary to take any action.
  • Possible deviation from normal process condition
  • This is a trigger, that something is going wrong means microbial count increasing that area.

Action Limits:

  • When microbial count reach this action limits then action is mandatory.
  • To control the  microbial count in the area.
  • Signal an apparent deviation from normal process condition And require immediate action.
  • If not controlled, we might get area failure.
These alert and action limits must be less than final limits.

Example :

Active air sample Grade -C Final limit 100.(as per EU -GMP,WHO-GMP, D&C schedule-m  and PIC/s).
to establish the alert limit based on trend analysis  -  20
to establish the action limit based on trend analysis - 24


Model -1

Sigma basis limits.

Alert Level

Alert Level = Average +2 X Sigma   
Ex: Average limit = 11.28 
Standard Deviation (sigma) =4.16 
= 11.28 + 2 X 4.16

=20

Action Level

Action Level = Average + 3 X Sigma

Ex: Average limit = 11.28

Standard Deviation (sigma) =4.16

=11.28 +3 X 4.16

=24

Model-2

Alert Levels

= Avarage +3avarage-std deviation

Ex: 9 + 39 = 9+ 3 x 3
 =18

Action levels: 


= Alert limit +3 alert limit-standard deviation

=18 +3 √18

=18+ 3 x 4.2

= 30

Ex :


1st Day
2nd Day

3rd Day
PWB001
12
14

14
PWB002
11
19

10
PWB003
10
20

12
PWB004
7
6

11
PWB005
4
8

10
Average
8.8
13.4

11.4
Average = 8.8 + 13.4 + 11.4 / 3 =
11.2

Standard Deviation:

(8.8-11.2)2  = 5.76

(13.4-11.2)2 = 4.84

(11.4-11.2)2 = 0.04



=5.76 + 4.84 + 0.04 /3-1
 = 1.63



What is the fumigation and fogging?

What is the fumigation and fogging?