India Local Networking Group

Dear All,

Can any one comment for the below proposal with our approved files.

We have an approved batch scale of 1120 kg for one of our API which are available in both USFDA and EDQM filing. Due to process optimization, we had performed few RND trails and concluded to execute with the commercial scale based on the validations. We would like to downscale from 1120 kg to 560 kg since we do not directly go with aforementioned changes with the current batch scale of 1120 kg initially. (Please note that 1120 kg is also manufacturing in lot wise process(Lot 1: 560 kg + Lot II :560 kg) prior to milling and blending for 1120 kg batch scale). Our question is whether we can add 560 kg as a smaller batch scale to our existing application  Or do we need to downscale from 1120 kg to 560 kg now?.

In future, we also need to bring 1120 kg scale for capacity increment. Kindly suggest.

Dear All,

Can any one comment for the below proposal with our approved files.

We have an approved batch scale of 1120 kg for one of our API which are available in both USFDA and EDQM filing. Due to process optimization, we had performed few RND trails and concluded to execute with the commercial scale based on the validations. We would like to downscale from 1120 kg to 560 kg since we do not directly go with aforementioned changes with the current batch scale of 1120 kg initially. (Please note that 1120 kg is also manufacturing in lot wise process(Lot 1: 560 kg + Lot II :560 kg) prior to milling and blending for 1120 kg batch scale). Our question is whether we can add 560 kg as a smaller batch scale to our existing application  Or do we need to downscale from 1120 kg to 560 kg now?.

In future, we also need to bring 1120 kg scale for capacity increment. Kindly suggest.

Dear All,

Can any one comment for the below proposal with our approved files.

We have an approved batch scale of 1120 kg for one of our API which are available in both USFDA and EDQM filing. Due to process optimization, we had performed few RND trails and concluded to execute with the commercial scale based on the validations. We would like to downscale from 1120 kg to 560 kg since we do not directly go with aforementioned changes with the current batch scale of 1120 kg initially. (Please note that 1120 kg is also manufacturing in lot wise process(Lot 1: 560 kg + Lot II :560 kg) prior to milling and blending for 1120 kg batch scale). Our question is whether we can add 560 kg as a smaller batch scale to our existing application  Or do we need to downscale from 1120 kg to 560 kg now?.

In future, we also need to bring 1120 kg scale for capacity increment. Kindly suggest.

Thanks dear.

So, should we file it as an amendment to USFDA with the validation along with the minimal stability to US.

I feel that for EDQM would be a concern since, we already mfg lot wise until milling with the proposed batch scale of 560 kg. if we propose 560 kg as a small batch size means in EDQM application, will they considered as valid change?

Dear All,

Can any one comment for the below proposal with our approved files.

We have an approved batch scale of 1120 kg for one of our API which are available in both USFDA and EDQM filing. Due to process optimization, we had performed few RND trails and concluded to execute with the commercial scale based on the validations. We would like to downscale from 1120 kg to 560 kg since we do not directly go with aforementioned changes with the current batch scale of 1120 kg initially. (Please note that 1120 kg is also manufacturing in lot wise process(Lot 1: 560 kg + Lot II :560 kg) prior to milling and blending for 1120 kg batch scale). Our question is whether we can add 560 kg as a smaller batch scale to our existing application  Or do we need to downscale from 1120 kg to 560 kg now?.

In future, we also need to bring 1120 kg scale for capacity increment. Kindly suggest.

Dear One,

Kindly confirm if we can go ahead with the above approach?

Thanks dear.

So, should we file it as an amendment to USFDA with the validation along with the minimal stability to US.

I feel that for EDQM would be a concern since, we already mfg lot wise until milling with the proposed batch scale of 560 kg. if we propose 560 kg as a small batch size means in EDQM application, will they considered as valid change?

Dear All,

Can any one comment for the below proposal with our approved files.

We have an approved batch scale of 1120 kg for one of our API which are available in both USFDA and EDQM filing. Due to process optimization, we had performed few RND trails and concluded to execute with the commercial scale based on the validations. We would like to downscale from 1120 kg to 560 kg since we do not directly go with aforementioned changes with the current batch scale of 1120 kg initially. (Please note that 1120 kg is also manufacturing in lot wise process(Lot 1: 560 kg + Lot II :560 kg) prior to milling and blending for 1120 kg batch scale). Our question is whether we can add 560 kg as a smaller batch scale to our existing application  Or do we need to downscale from 1120 kg to 560 kg now?.

In future, we also need to bring 1120 kg scale for capacity increment. Kindly suggest.