Sampling in process validation

Hello there,

In the validation of film-coating tablet process, I see my colleagues take samples to check weight uniformity. The validation would be carried out on three different speed, and at each speed, they take samples (20 tablets) at initial, 15 mins and 30 mins. Then they check weight of every tablets.

The thing makes me confused is that they also randomly check the total weight of 10 tablets at each timepoint. What is the meaning of this action?

Thank you for spending time reading my topic.



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The purpose of weight checking is to check the amount of coating material deposited on core tabs during coating.
in film caoting 3_5% coating material is used.
in enteric coat 10_12 % is used.
after regular intervials monitoring of wt indicate that coating material wt is deposited to tabs or exaust out

Thank you for the answer. Although the product is film-coating tablet, what I mentioned is in compressing stage. I just want to know the meaning of checking 10 tablets, in other words, what can be seen from its result?

to check following parameters
wt variation
Wt of individual tab and avg wt of 10 tab both are cheched .individual wt is checked to ensure that that no tab is out of defined limit.

Compressed Weight of tablet 10 Tabs is randomly checked, in order to avoid and control weight variation and it is expected that if the weight of the tablet is ok, then other parameters will generally be within limit. anyway for other test parameters, the frequency is either half hr or hourly, depending upon SOP.


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