Stability Study - Processing Stab. Study without Initial Sample

[carlos_tese]

Hello

Our customer requires to process the Stability Study without having created nor inspected the Initial Sample.

All revised documentation states that the initial sample is required to process the notification.

Any suggestion to comply with this requirement?

Thank you

[sourabh_maheshwari2]

the main reason to have an initial sample is to ensure that they can proceed with the remaining study as well as perform tests that they might not perform on the regular batch

In case your customer already performs all the tests for the batch that would be performed in the stability study, then you can enable the copy functionality and allow the results to be copied over in the inspection lot for stability. They do not need to perform any tests and will save time (i believe this might be the reason they don't want the initial sample)

[carlos_tese]

Thanks for the answer. The problem is that the inspection for the initial sample is done in an external lab.

I'm going to manage this creating the initial sample but not recording the results.

Just creating the initial sample inspection lot the system allows to process the the next steps of the study.

[former_member702860]

Hello Carlos,

I agree with Sourabh, the initial sample is essential to proceed with the remaining of the study. All physical samples processed in the stability study are associated with one physical-sample drawing number, which is created automatically by the system when you create the initial sample.

However, the initial sample inspection can be skipped by creating a new status profile in which the following status CRIL, ILCR, COIL (process steps for the initial test inspection) should be removed. By doing so, you will directly proceed with the stability planning and the stability test after the initial sample confirmation.

[sourabh_maheshwari2]

generally stability results are submitted to FDA or local regulatory body

that is why it should never be skipped

[carlos_tese]

Thanks for your answers. As I explained in the other comment it is possible to proceed with the stability planning just creating the inspection lot for the initial sample.

the results recording for the initial sample is going to be needed just to complete the stability study.

Now I have another problem, how can I set the system to automatically create a Purchase Order for the Operations in the inspection plan executed in an external lab?

I have created a new control key (+ External processing assigned), assigned to the Operation to be executed in the external lab.

For this operation, Ive set the Subcontracting indicator in the External processing section and assigned an Purchasing info rec. without material reference as the system asked.

With this configuration the system is not creating any Purchase Order.

Thankyou so much