Temporary Change with the same BPR(Batch Processing Record)

GOOD MANUFACTURING PRACTICE (cGMP)
#1

Dear ALL

We have the following practice for tempory changes (for eg 3 batches ) in the manufaturing of API
for eg
if there is a change of reduction the quantity of solvent by 6%,we used to strike out and sign the quantity in the respective BPR with the new solvent QTY by QA .

Is the pracice is accetable in regulatary environment or
we should go for revise the BPR for change in solvent qty

can any one pl explain

THANKS
SBD

#2

Interesting question !
Practice is good enough as it is considered as a transciptional error during preparation.But it is to be corrected in the next version of the document.meanwhile it is to be informed to regulatory agency.

Thanks,

MUKESH VARDE

#3

Not accepted , due to this is typo error , it is OK , but if you want change with planed , should be go/ change thought change control form

#4

Dear All

If the product is DMF filled do not change .Take the planned deviation check the three to five batches data after complete of all batches check the Quality and yield ,if it is OK change the Temperature through the change control system and approval Regulatory department