Process Validation using different lots of API

dear all,
good day. hope you all are well.

please help me on following issue.

is there any criteria or regulation regarding process validation that the validation batches (3 batch) to be manufactured using same lots of API. or different lots can be used as well.
please help me with reference.

thank you in advance.


There is no specific regulation for this. You may use different lots of APIs in the Process validation 3 batches. Please ensure that the API is having same QC specification for testing and all the lots must be manufactured by the same company (Same vendor source).


thank you. yeah. right .
i think using different lots of same source will make the process validation more robust.

thank you again.

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Yes, absolutely.

Thank you so much

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You are always welcome.

Can we validate batch of two different vendor of same API in 3 validation batches ?

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No, please.

TGA, Australia recommends in its guidelines that PV is carried out using at least 2 different lots of API.

yes, we can use two different lots of API in one PV study. But those lots must be from the same vendor (Manufacturer).

It’s better to use same lot so that the API potency remains same or else there may be difference in d final results due to different potency.

wouldn’t it be good to see right in the validation if the manufacturer is not relevant, to produce 3 validation batches with different manufacturers?

@Georgija I think I understand your point, but PPQ runs must consider variability within same vendor of API. If you want to evaluate variability between different manufacturers, then you’ll need to replicate PPQ efforts for each manufacturer.

For example: if you have 3 manufacturers of API, and you do 1 batch for each manufacturer, then you only have data of 1 lot for each manufacturer. You don’t have enough data to evluate variability from same manufacturer.

To mitigate this, you would need to perform 3 batches for each manufacturer (9 in total) to have enough data to statistically demonstrate performance and consistency of the process with API for each manufacturer. This would be the same as performing 3 different PPQ’s, each one consisting in 3 PPQ batches for a specific manufacturer of API.

I understand all but sometimes you do not have that much batches at all, for years…thank you

You can always validate your process with 1 API manufacturer to start comercial production first, and then plan ahead to evaluate additional manufacturers if needed. There is no need to rush and evaluate several manufacturers of API at the same time to then start releasing lots prospectively.

Also, when dealing with products with limited demand, you can use a Concurrent Release approach, as described in FDA guidance for Validation (Guidance for Industry Process Validation: General Principles and Practices). This will allow you to release PPQ lots for distribution before complete execution of PPQ protocol.

You would still have to comply with specific requirements to account for the risk of concurrent release, but that is what risk management is about.

Please what is the full meaning of abbreviated PPQ?

Process Performance Qualification, as per FDA guidance on Process Validation: Process Validation: General Principles and Practices

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