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.
"Any proposed change to the manufacturing process should be evaluated for the impact on the quality of drug substance and, when appropriate, drug product. This evaluation should be based on scientific understanding of the manufacturing process and should determine appropriate testing to analyze the impact of the proposed change." ICH Q11; see also examples in the guide lines.
Yes. Any change in manufacturing process needs validation so as to ensure getting the esteemed product.
The change is not in the process of manufacturing only on the supplier of the API which is already controlled by specifications and it conform with our specefication
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