Hold time study

Quality Assurance
1

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

2

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

Thanks

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