what are the PQ parameters for granulation machine
If more than 30 products to be manufactured on this granulator how many product selected to run to qualify its performance.
Should it be covered through complete process validation?
[quote=ilu]If more than 30 products to be manufactured on this granulator how many product selected to run to qualify its performance.
Should it be covered through complete process validation?[/quote]
No complete process validation is not required for performance qualificaiton of Granulator.
The process variables for granulator are:
Load of powder to be granulate in the granulator
density of the mixtures
Viscosity of the granulating fluid
Binder Solution Flow rate
Agitator speed etc.
as mentioned in your URS of Granulator
Now run the qualification testing considering all the above parameters and get the result of PQ.
A single product testing can be done for PQ. It may be dummy one as PQ is testing of equipment but not that of the product.
Hi daprawan. I am having an uphill battle trying to influence the “top” management with the PQ reuirements for Process equipment. We (Qualification Department) would like to test the equipment as per our URS specs but are now being ‘forced’ to include the likes of product particle size, assays, moisture content, friability, etc. The interpretation is lost between Process Validation and Equipment Performance Qualification. Where can one find the performance qualification requirements in "black and white’?(FDA, MHRA,WHO)