Process Validation Equipment

Validation
1

How important is to include Tablet Deduster and Metal Detector in Process Validation?
Do we need to identify critical quality attributes for them too ?

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2

For compression process major equipment is Tablet press for Tabletting process, and here we need to define Critical process parameters such as pre-compaction force, Main Compaction force, Feeder RPM, Fill depth.etc.
CQA (Critical quality attribute is nothing but Tablet physical. analytical-chemical properties or the limits, specification)

As the Metal detector and deduster are considered as accessory equipment and does not contribute to CPP and CQA.

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3

Thanks Asif, appreciate your help.

I actually came across a process validation protocol of a tablet, In which the tablet deduster and Metal detector are not mentioned, not even in manufacturing process description. Is it okay? if we are not mentioning additional equipment like : deduster and metal detector.

4

yes absolutely in Process validation u can exclude these kinda equipment’s but remember these equipment’s one should use in batch after proper qualification and documentation.

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5

Great! that helps.

Thank you