Sample management !!

[Former Member]

Dear Experts,

I have a scenario in my project,

At time of finish good inspection(say 1000 jars produced), (inspection type 04), we are drawing 12 Jars as a sample(fix).

Now these 12 jars will be kept in a sample house untill the Product expiry will be reached.So through QA11 we will move 988 jars in restricted and 12 jars in Reserve.

Now again after every 3 months, 1 jar will be drawn for sample house and inspected and recorded the results.

How to map this scenario with Physical sample concept.

Whenever a insp. type 04 is triggered, can system will create automatically 12 Physical samples(12 physical sample ids) so that every 3 months through QPR5 manual inspection lot will created.

Please suggest the solution.

Thanks

[Former Member]

Now again after every 3 months, 1 jar will be drawn for sample house and inspected and recorded the results.

Stability study can be precisely used for the same.Otherwise if material is batch mgt then you can use 09-recurring inspection for the same along with physical sampling.

[Former Member]

Thanks Sujit for your reply.

Suppose i have one Physical sample(say 100001), and against that I create a inspection lot(say 150000001) through QPR5. Results are recorded and UD is done against the inspectin lot.

Can I create a inspection lot for the same sample(100001) again. I tried through QPR5 and its showing the message that inspection lot( 15000002) is created but same is not present in QA32.

Can you plz help in this.

[Former Member]

Can I create a inspection lot for the same sample(100001) again. I tried through QPR5 and its showing the message that inspection lot( 15000002) is created but same is not present in QA32.

No, for the simplest reason is this is not automatically created sample like created in 09 or 16 type of inspection.

in 09 data like Recurring inspection lot duration,SLED ,expiration,next inspection lot creation dates should be maintained.

in 16 inspection type maintenance plan for creating Stability study along with storage condition needs to be maintained.

This we can not do in the manual creation of physical sample.So system will not allow to create lot for same physical sample.

[former_member42743]

Sure. This would be in sample management. You have to create a sample procedure and sample drawing procedure that will create the 12 reserve samples.

Alternatively, you can but these into the stability system and have your lots automatically created for you.

FF