REQ concept of partial ToPartSampleNo, size facor and fixed no

[Former Member]

Hi

I want to know the concept of partial ToPartSampleNo, size facor and fixed no in sample drawing procedure. What effcets will they have on stability study?

It would be really helpful if someone can explain with an example.

Thanks in advance!

[former_member186399]

Dear Swarnali

That is possible when doing " Create Testing Schedule" in the stability study. There in scheduling period you will be able to maintain the time period

Regards

Gajesh

[Former Member]

Hi

Yes I did maintained 1 hour in testing schedule. But no tests being created. I am asking you few very basic questions:

1. If I maintain cycle in testing schedule, then where is the strategy used?

2. After completion of stability study, will there be lots generated in QE51 for recoding purpose? if so, Am not getting the lots

[Former Member]

Some of basics of Stability Study

1.Strategy actually determine the cycle ( like after every 2 days).

2.maintenance plan is actually created in background when you click on "create the schedule".In maint plan you only put Start of cycle.

3.Explore T code QST09

2. After completion of stability study, will there be lots generated in QE51 for recoding purpose? if so, Am not getting the lots

First lot will be for the Initial test -->1601

Second is for stability study --->16 will be created after you define start date of study through notification only.This lot is generated for a storage condition.

[Former Member]

Hi Gajesh and Sujit,

Thanks!

[former_member186399]

Dear Swarnali

Physical Drawing procedures are used majorly when there is a complex testing done such as organic content testing , chemical testing mainly in food, pharma industries.

Stability study is also a complex study where one study can take lot of time for completion as you are checking the stability of the product over a period of time.Stability studies are mainly based on samples which will under these categories primary , pooled and reserve sample. So always Physical drawing procedure and Stability are inter related.

Sample drawing procedure has the functionality of creating physical sample instructions. The parameters you mentioned in your question is basicaly used for instruction and calculation of sample quantities.

ToPartSampleNo : This is the highest partial sample number in the inspection plan to which the sampledrawing

item applies (for example, up to partial-sample number 003). When you create the next sample number it looks for a seperate Procedure

Hope you got some ideas.

Regards

Gajesh

[Former Member]

Hi Gajesh,

Thanks!

yes Am clear now. But another doubt in stability study. As am learning from best practice doument, they are using strategy QATABI.

Suppose for my own practice, i need to create tests in say every 1 hour for one day. Where do I maintain this?

[Former Member]

size factor Will multiply the primary sample by this much Qty.Say you have entered 2 this will create twice of primary samples.

fixed noFixed sample means sample is fixed irrespective of lot size.So when you are not using sampling scheme & needs fixed size you can use the same.

[Former Member]

Hi Sujit,

Thanks for your prompt reply. Its rreally helpful.

And for the partial sample, if I put 3...does that means i can create 3 no. of samples in RR? because I saw create button beside the field for physical sample no in QA32.

And another thing, though my intial sample is being shown in QA32, its not there in QE51N. Any special setting required for lot origin 16?

[Former Member]

Hi

Any input?