Hold time study

if our hold time period establish for particular product is it necessary to perform re hold time study
when formula change or
change in equipment or
change in formulation or
change in manufacturing site

1 Like

Kindly update me answers

Dear ,
Formula- if major change β€”Yes should be done.
Equipment- Similar/equivalent- No need. for different-Yes,
Formulation- yes
Mfg site- Yes



If route of synthesis or majer equipments or critical parameters or ksm change then reperforming required

If you performed process validation for any applicable change, then hold time study to be carried out.