Dear All,
I am new to this forum.
I would like to know the clarification from this forum.
An API need to process in a clean room facility, in that clean room the blender is not suitable for the pupose. in this case can the same API allowed to process in onther clean room facility which have a suitable blender.
As per GMP is it allowable or not?
Thanks in advance for the input.
T.Nageshwar:)
You can definately do the same API in another clean room where you think blender is suitable for operation, provided you have cleaning validation of that blender prior to use.You need to validate the bledning process to see that the blender is suitable for this product and you get desired result from blending process. You may also need a change control for changing the blender and room number. Hope this will help you.
Stanely
[quote=drmirajkar]You can definately do the same API in another clean room where you think blender is suitable for operation, provided you have cleaning validation of that blender prior to use.You need to validate the bledning process to see that the blender is suitable for this product and you get desired result from blending process. You may also need a change control for changing the blender and room number. Hope this will help you.
Stanely[/quote]
Dear Dr.Mirajkar.
Thanks for the prompt reply.
I agree with you to validate the blending process. We have two clean rooms each in separate blocks(Block A and B). We processed the material in Block-A upto drying stage. The dried material need to transfer to Block-B for further process ( Milling and Blending). for this activity what procedure I have to follow to fulfil GMP? and as this is a part of validation is it need to show change control?
Thanks in advance for your promt reply.
T.NAGESHWAR