Validation of punches and dies

Hi all , do we have to validate a set of punches and dies on every press machine knowing that constractor of the press is the same for all the machines and why thanks :slight_smile:

It is not required to validate the punches and dies of the tablet compression machine.
Generally, upon receipt of new punches and dies, there are checks to be performed such as MOC, Dimensions, embossing, and finishing. The acceptance criteria should be set according to the approved design of punches and dies.

During process validation of the tablet manufacturing process, it is required to validate the compression process of every die and punch set (upper & lower punch and the die) being used in the compression machine (such as the physical dimensions of tablets compressed on every punch and die station along with other critical process parameters such as compression speed, compression force, etc.
Periodically all punches and dies must be checked for any damage or corrosion or scratch on the polished surface etc. Dies and punches must be maintained properly and lot of care is required to be taken to increase their life, such as proper cleaning, drying, greasing and safe storage to avoid physical damage.
Also, it is preferred to maintain a logbook to record the number of tablets punched on specific sets of dies and punches over a period of time in order to determine the lifecycle and rejection criteria of used dies and punches.

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Thanks sir for your answer is there any guideline or official text to prove that ? . Thank you

that the validation is not required