QM- STABILITY STUDIES

[Former Member]

Dear friends

How to do stability study using QM. Is it done through notifications.

During stability studies are we monitoring the product over a time range or by doing some tests. How is the stablity of a product studied in QM. Pls explain.

Kind regards

Selva

[Former Member · Accepted solution]

Hi Selva,

One more link for details on STABILITY STUDY and how it is done in SAP

[STABILITY STUDY IN QM|http://help.sap.com/bp_pharmav1600/Pharma_DE/Documentation/P56_BPP_EN_DE.doc]

Thanks,

RAVI.

[former_member184536 · Accepted solution]

hi Ravi

Please share the document. I think it is offline .  I want to learn stabilty study.

Thanks in advance

Manish

[former_member184536]

hi freinds

I m also new to stabiltu study. i have go thorugh the post and read the article . i have done everthing. But i m no able to make the inspection plan for storage condtion .

Can anybody how to create the inspecttion plan for storage conditions.? Because i m getting error that testing scheude cannot be completed as no taslkist is assigned to maintenance item 202..?

Please help me out/

Thanks in advance.

Manish

[Former Member]

Hi

Before i entered old data in our SAP system. But today i make one plan. start date 26.01.2014 and 3M,6M,9M,12 ,18 and 24 but when i start with IP10 i found only One planned created by system 24M

how to resolved the issue please ........

[Former Member]

Dear RKM

Thanks a lot for the details.

regards

Selva

[Former Member]

Dear RKM

A notification can be created after lot creation. But is it the starting point in stablity study to create a notification first (because the SS notification has only tasks and activities).

Shall I have a small example and some more details on how the stabllity study is monitored with the possible t-codes and mandatory entries for these t-codes please.

regards

Selva

[Former Member]

Hi Selva,

The Question while doing a SS is to test whether Material has the required shelf life to considered fit for use.With this is view, SS carries out in stages as detailed in the above thread.

For Example, let us say we sample of a Mat A send for testing in Lab.

1.Create SS

We need to start the Process of SS in SAP with the Initial Sample received.We do this by creating Q.Notif. type QS ( with Material) or QR (w/o Material).

2.Initial Test

We have to carry out Initial test on the sample before we accept that we can take this forward for testing in future for Shelf Life Study.

Initial Test would be like some test on charcteristic of Mat. A that would assure that the Material is actually Okay wrt what it is expected to be initially.

3.Stabilty Planning

Stability Planning defines future dates in which the Mat A needs to be tested in.It also defines the Storage condition in which the samples would be stored as per the test condition.What dates the Test will be carried out in future.

4.Stabilty Test

On all those dates as planned in future the Inspection Lot would be created automatically and we would need to record result and take UD to record if the tests are okay or not.

5.Complete Stabilty Test

After all those test dates are over, we need to clear the samples and close the SS.

A notification can be created after lot creation.

No.It can be creted w/o creating a lot.

Remember SS is a diffeternt approach than conventional Inspection Planning. It is integrated with Qual. Notification to assist in the Process.

how the stabllity study is monitored with the possible t-codes and mandatory entries for these t-codes please.

It is fairly simple as once you create the Notification as detailed in Step 1, Action Box on the RHS would guide you on further steps.You need not worry about T codes here.Just create a Notification and it will guide you further.

Further read on the Stability Study -

[STABILITY STUDY|http://help.sap.com/saphelp_erp2005/helpdata/en/d2/7c9c3b566ac466e10000000a114084/frameset.htm]

Try it out once

Thanks,

RAVI.

[Former Member]

Dear RKM

Thanks for your guidance. Will revert back in case of any clarifications needed.

regards

Selva

[Former Member]

Hi Selva,

You can initial SS by creating Q.Notif. type QS ( with Material) or QR (w/o Material). Once you create a Qualty Notification, the Action Box guides you to the next step, so it is pretty simple

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Various steps involved in SS are:

1.Create SS

Create Initial Sample

Confirm Initial Sample

Assign stabilty BOM

2.Initial Test

Create inspection lot for initial sample

Perform initial Test

Complet Initial Test

3.Stabilty Planning

Define Storage condition

Store stabilty sample

Create testing schedule

Change Testing Schedule

Complte testing svhedule

4.Stabilty Test

Start Date for Stbilty Test

Schedule stabilty test

Execute Stabilty Test

5.Complete Stabilty Test

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All steps are trigerred by Follow up action in the Notification and is almost self explanatory.

Do get back in case of any problem.

Cheers,

RKM.