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.

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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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On how many batches?

Typically one or more batches of the material, intermediate or product
can be used for determining hold times. A risk-based approach can be used to
determine the appropriate number of batches, considering the characteristics of
the materials and other relevant aspects. A representative sample of the batch
of material or product subjected to the hold-time study should be held for the
defined hold period. The hold period for each category of material should be
established on the basis of the study by keeping the material in either the original
or simulated container used in production. The containers in which hold-time
samples are stored should be the same pack as is used in production unless the
pack is exceptionally large, in which case one that is equivalent (constructed of
the same material and using the same closure system as the production packaging
system) may be used. Reducing the size of the container, when this is necessary for
testing holding time, should be justified.

Reference: WHO Guidelines, Annex 4, General guidance on hold-time studies WHO TRS 992-2015

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