hello
should BMR be seperate from the packing record .
do we have to write each step of manufacturing: weighing, mixing, granulation … in a seperate file.
do we have to check temperature , humidity and pressure differential before each step… and record it?
and what should we do with blisters that are improper. can we de blister it and rework it? shall we record that?
Yes everything about the manufacturing should be written in BMR.
Sir, can you please send me a batch record for parenterals?
Dear Sir I am working in chemical industries where is better opportunity for me I want to change my Line. Is that better for me
It depends , usually both bmr and bpr are in one file.but recording of each step of manufacturing is to be done in batch manufacturing record.checking of temperature,humidity and pressure differential shall be in both the portions.i.e bmr and bpr.
Yes everything to be documented, Regarding improper blisters, it can be defoiled and shall be reblistered during end sift hours and documented.
Batch manufacturing record contains manufacturing process, material requirements, process in details step wise including packaging , general & environmental condition & all stage reconciliation.
Few organization have IH procedure to nomenclature batch manufacturing record for manufacturing process except packaging & batch packaging record for primary,secondary & tertiary packaging process.
Few organization collectively nomenclature as BPCR.