I wan to know if there is a guidelines that Change of supplier of the Active pharmaceutical require a process validation of the finished product or it depends on the dosage form. On the other side if the specification of Active pharmaceutical ingredients from different suppliers are the same no process validation is required. I wan to know if there is a guidelines that Change of supplier of the Active phamaceuttical require a process validation or it depends on the dosage form. On the other side if the specification of Active pharmaceutical ingredients from different suppliers are the same no process validation is required.
As answered before, it will depend on the regulation on each country. For Brazil, please check the current Anvisa's guideline (RDC 73/2016).
Yes, it is required. But it depends on the drug controlling authorities and the countries following pharmacopeia, all of the topics been described in details in every piece of pharmacopeia.
For EU, US, Canada & Australia also this change needs to be validated. also such change in API supplier has to be one of the trigger for process validation in your validation master plan. at least mixing stage has to be validated fully to justify. Batches to be charged on LT & ACC stability as per approved protocol.
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