Hold time study

Quality Assurance
1

it is necessary to establish again hold time study when
1)formula change
2)API vendor change
3)Batch size change
4)Equipment change

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2

Ideally speaking yes. Otherwise you will have to justify why hold time studies were not performed. This is because change in formula, or API vendor change or batch size change or equipment change might have impact on characteristics of the intermediate products.

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3

if any Major changes in process needs to be validated and conduct stability also.

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