Stability Storage Condition

[Former Member]

Dear All,

1)During Stability Notification Creation in step "specify Storage Condition" which quantity have to enter ?

1. Scenario Is like Below

Strategy Assign : QST180

Packages : 30,60,90,120,150,180 Days

Storage Condition :00000000001 Quantity : ??

and for each package cycle sample quantity Define in task list (Sample Drawing Procedure) Is 3 EA

Total Sample 18EA(6 * 3) is required

Initial Sample Size-18EA

So we move 18EA Qty into Storage Condition 00000001 .

so why in the field i have to enter qty 3?

2)Inspection Lot Size

and if i enter qty 18EA in Storage Condition in that case

for each package 6 inspection lot got generated and each lot size is 18EA and sample size is 3EA

but i required a lot size only 3 EA and also sample size 3 Ea

For that what setting i have to so?

Regards,

Murari Shah

[Former Member · Accepted solution]

Dear Murari,

In one particular Stability study you would be splitting / dividing the samples to different storage locations.

You need to define respective quantity to respective Storage Conditions.

so why in the field i have to enter qty 3?

Is correct. it means

00000004 - ~~~Temperature 40° you are allocating 3 EA out of 18EA then assign it there.

00000005 - ~~~Refrigerator 7° if you are assigning 15Ea then assign it there.

When you will create inspection lots, it will be created against these storage locations. where you the inspection lot quantity = the quantity that you have assigned earlier.

i.e. system will create two inspection lots for two storage conditions.

Regards,

Shyamal

[Former Member]

Dear Shyamal,

Thanks for reply

Storage Condition : 00000001(25C)

Packages : 30,60,90,120,150,180 Days

As per attach task list 3 sample required for each cycle testing

so initial sample size 3 * 6 = 18EA

1> so in define storage condition if i enter quantity 18

in that case at a lot creation at every cycle lot size system taken is 18 and sample size 3

so total 6 lot create of lot size 18 EA

but i required lot size 3EA for every lot

2> and if in define storage condition enter quantity 3

in that case lot create of lot size 3 EA

so total 6 lot create of lot size 3EA

In this case when i am going for print a Storage list system showing me total sample under Storage condition is 3

but i have stored a 18 Sample There.

Regards,

Murari Shah