if i have some tablets that not comply to standards, should i store it to the next batch. can i mill it and re compress it?
if the answer is yes, where do i have to store it?
should i write it in the BMR.
if i have blisters that misses tablets. should i rework it?
please guide me.
should i write SOP’s for that?
is it contrary to GMP?
Dear,
Copying the same…
if i have some tablets that not comply to standards, should i store it to the next batch. can i mill it and re compress it?---------If not complying specs, dispose it or follow company norms.
if the answer is yes, where do i have to store it?-----------As per specified storage condition of product.
should i write it in the BMR.--------Not applicable if not disposing, as per company management decisions.
if i have blisters that misses tablets. should i rework it?--------deblister and reblister and the end of shift of packing.
please guide me.
should i write SOP’s for that?--------In general SOP can be included.
is it contrary to GMP?------Reblistering is non contrary, unless there is no defect.
Thanks
make sure the deblistering and blistering process is validated . Detail need to be in the SOP of the deblistering process.
Pay attention to the deblistering machine ,can cause cosmetic defects ,eg marks , spots etc .
This was actually audited ,the deblistering process !!!