Hold time study for intermediate bulk tablet products

Regarding hold time study for intermediate bulk tablet products in a pharmaceutical multi-product company

Is it acceptable to select certain worst case tablet products to represent all tablet products of this multi-product company so as to perform sampling and testing only on these selected worst case tablet products in order to generalize their results to all tablet products of the company ?

Note: I mean by worst case products , the products of the highest risk of instability & microbial growth

Thanks a lot

Ideally speaking hold time study of tablet products should be performed for each product individually. It would be appropriate to perform hold time study of bulk tablets during process validation exercise.


Ideally we should to carry out hold time study for bulk tablets for each product.

or you can go for bracketing approach if the product having different strength ex-let olanapine 5mg, 10mg, 20mg, 30mg Tablets by risk assessment. and testing can be performed as matrix way in different interval of storage period.

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