on 03-15-2010 9:20 AM
HI
Kindly explain me what is batch monitoring amd stability study in quality. how i can maintain in quality. explain me in brief.
Hi,
Stability study is concept used in pharma industry .
In material master Pre requisite.
Ispectio type -09, 15, 16 ,1601, 1602 you need to activate.
Material should Batch Managed.
IP11 you need to maintain strategy normally offset strategy is used fir stability.
Inspection plan should be available with usage 9
Once your batch is unrestricted use you can do stability study.
QST01 or QM 01 you have do in this transaction ,create iinitial nspection lot
CWBQM is also transaction where you need to assign packages ( Packages defie in IP11 )
Ip10 to released inspection lot.
Like wise you can do it .
Regards
SANIL
If batch monitaring means you mean to say recrring of batches then you have make varient in T Code QA07 ( you can crate it on plant level ,material )
Give shelf life in material master for expiry date calculation ,Interval days in QM view for calculating retest date.
Edited by: Sanil Vadke on Mar 15, 2010 11:25 AM
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