Stability study - Testing schedule

[#1]

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]

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.