Equipment revalidation necessary with new cutting oil?

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
1

Hello,

We are in the process of changing the cutting oil in our CNC Swiss Screw machines. Is equipment revalidation necessary here? In IQ and OQ, cutting oil hasn’t been specifically called out, but the proper operation of the oil pumps and supporting equipment is necessary.

I understand the cleaning process will need to be revalidated to ensure complete removal of the oil. My question is specifically whether or not equipment needs revalidation when a new cutting oil is used.

2

Do a risk analysis (and document it). If there is risk to the product quality then maybe some re-validation is in order. If there’s no risk, then probably not.