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Stability study - samples storage in feature dates

Former Member
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Hi QM Friends,

Is it possible to store stability study samples in different location with feature dates.

My scenario is client want to create stability study and some storage condition immediately the want to store samples but some storage condition they would like to store in feature dates in the system (example 24.09.2010), so that on that day ohysically they keep the samples in respective location by the time they don't want to change in stability study.

Could anyone pl.give your comments.

Krish

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Answers (1)

Answers (1)

former_member42743
Active Contributor
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I think instead of "feature" you meant "future".

I'm not sure I quite understand the requirement.

You want to create a stability study today. Let's say with 20 samples. Today all samples are maintained in a storage location that is normal temperature, say 70F. But come September 24, 2010 they willl start storing 5 of those samples in a cold storage locker (a different storage location) at 30F. You want the system to automatically handle this change of location on 24.09.2010.

Is this correct? I would say offhand, that no, SAP has no standard functionality for this. I would also suggest that this would be a very bad business process from a QM view and could very well jeopardize the validity of the stability study if reviewed by a regulatory agency, (at least the FDA would frown on it I'm sure).

If you were to set up such a system, there is no positive check that the samples were actually moved on the day they were supposed to be. What if the day happenned to fall on a weekend or holiday? What if the person who was supposed to do this called in sick? Got hit by the proverbial bus? Had an argument with the boss and just said "screw it"? Unlikely I know. But it happens.

And yes, someone could go into SAP and manually make the updates and then one of the above things happend and the samples still don't get moved. But that it is less likely if you have someone manally doing the SAP transaction.

What I could see however would be a process where a reminder is generated to make the moves. And then after the moves are done the user updates the system. This could probably be fairly easy to set up as a task (maybe right in the stability study via an action box), and if the task has an expected end date, workflow could be used to send reminders out or escalate the task to make sure the samples are moved.

FF

Former Member
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Hi FF,

I agree with you and i am also ware of FDA.

I am also thinking standard SAP will not support this requirement. I have recommended to the client to those storage conditions whenever required to add storage condition, so that before the store in storage condition they can do, obviously they must update testing schedule.

My Question is that inspection lot for those condition will be created automatically. I tried in deadline monitoring it didn't. can you please confirm for those condition whether we have to create manual inspection lot.

former_member42743
Active Contributor
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I can't say with 100% confidence but I beleive if you add a new storage condition you can add these samples to the test scheduled and your inspec.. lots will be automatically created.

But don't take my word on that. You'll have to test it.

FF

Former Member
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FF,

No. Inspection lot is not created automatically.

Can anybody have idea pl. suggest me.

Thanks