Stability study - Testing schedule

[Former Member]

Hi,

I need to manage a stability study with a testing schedule to create inspection lots as follows:

3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, 48 months.

How do I do?

Can you help me? I'm apologize for English.

G

[Former Member · Accepted solution]

Hi,

Create offset strategy with T code u2013IP11 u2013where you can give period in packages 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, 48 months.

Donu2019t give cycle length

Hieirarchy for all packages give 1 ,hi text give for all as per your requirement.

Off set text give - 3,6,9,18,24,36 like your packages.

Regards

SANIL

Edited by: Sanil Vadke on Apr 27, 2010 1:41 PM

[Former Member]

Ok thanks for the help.

I have one last question:I am implementing the study of stability for a pharmaceutical company. They tell me that the GMP (good manufactory practice) regulatory require that stability study should be planned based on the date of production batches.

Example: receiving a sample in April 20, 2010, but the date of production batch is March 26, 2010. The stability program should start considering how to start date March 26 and not April 20.

Can I force a start date prior to the date of sample receipt? If this is not possible as I do?

G.

[Former Member]

Thanks Sanil, it work!

I still have two questions:

1) Using your solutio the inspection lots are created considering the start date, right? So if I create a inspection lot after one month and then the next three months after its predecessor, in fact I have set as an offset: 1 Month and 4 Months?

2) If another material for my stability plan is different, for example 3 months, 6 months, 12 months, 24 months. I have to create a new maintence strategies (T-code IP11) ZQSTABI with its packages?

G.

[Former Member]

Hi,

If your different material is having different plan then you need to create seperate different strategy for that material as 3 Month,6 month ,12 Month ,24 month

Regards

SANIL