Performance Qualification on a Tableting Press/Compressor

Hello everybody.

I am currently doing a study for PQ for a tableting press (also known as a compressor). I have to write up a PQ protocol for this specific equipment.

Basically just to clarify, this tableting press is used to compress the granules into the tablets in pharmaceutical industries.

The tablet in question would be “Paracetamol”.

I would like to ask besides following the USP to determine the tests needed for the paracetamol (such as heavy metal tests, etc) what other tests would i need? Im thinking along the lines of friability test, hardness test, thickness test, etc. Please do help me out here.

Also, what is important and included in a PQ protocol?

Thanks everyone! :smiley:


Perhaps you should consider as well the process capability, Cpk study. This is the study of the capabilities of the tablet press machine.

The friability, hardness and thickness test is more to process validation of the paracetamol.

If you wish to qualified the tablet press machine, might as well you consider all this parameters in your PQ, including the Cpk.


Hi all,

Do you have any samples for PQ protocol for tablet press machine or anything related to this equipments? I would like to know the format for PQ protocol, how to write, what other tests to be included for this protocol.

Im really desperate to know it as i’m required to write a PQ protocol for tablet press machine. Do help me and thank for your help in advance =)

Hope to hear fro you guys!