At compression of tablet, as per Batch Manufacturing Records (BMR) we have to check Average weight of tablets at 30 minutes interval. Last inprocess done at 11:00 am that time Avg. wt of tablets is within limit. But at 11:30 avg. wt of tablet is not with in limit.
Then what to do? How to proceed further.?
Plz explain…
firstly, you must have an sop (written standard procedure) in place which tells you how to do your checks [weight, hardness, thickness, friability, disintegration…]. then the sop needs to state “if the check does not meet parameters then…”. most important to the FDA is ‘have a procedure in place and follow that procedure’. your procedure should state what to do in that situation. first step could be to segregate the material produced within the last 30minutes and let the quality department make an assessment. then do another check right away with other tablets- if it is still out of spec then make an adjustment to the machine to bring it back into parameters. if you can quickly get the process under control then you are showing that you have control over the process. if not, then there is perhaps some mechanical problem, or maybe you have a bad blend, or perhaps the technician does not know how to operate the press? there should also be a procedure which tells you what to do if you are in the middle of a process validation and you cannot meet spec.
1 Like