Type of investigation

[meenakshigupta72 (Meenakshi Gupta)]

If a bottle is having 50 tablets and market complaint is one different color tablet in that bottle, then which type of investigation shall be done ?

[sunilrbudhkar]

Hello,
First, you will have to evaluate whether this is a valid complaint or not by a thorough investigation. You can request the complainant to send the complaint bottle along with the “Different coloured tablet” he has found. Please confirm that the odd coloured tablet belongs to your company through its appearance and analyse for identification test of active ingredient(s) in it. Whether the complaint bottle is sealed or the seal was opened by the complainant? If in a sealed bottle, one can see through the different coloured tablet then the complaint is valid. OR If it is confirmed that the odd tablet belongs to your company, then this complaint will have to be investigated on the following grounds.

Identify which tablet product is this.
Review Batch mfg & pkg records of the complaint product.
As this is a tablets “Mix-up” case try to find out what was the previous product packed before the complaint product batch was packed on the same packing line or adjacent packing lines. Find out whether the odd tablet product was mixed up in the other bottles packed by observing the control samples.
Try to find out whether there were any lapses in certifying the “Line clearance” by the QA person as he might have missed out the presence of the previous product on the packing line where the complaint product was packed in bottles.
Also, get the invoice/bill of the pharmacy shop from where the customer has purchased the complaint bottle and get more bottles of the same batch number from the same pharmacy shop to investigate further.
Try to find out root cause(s) of the complaint and address it appropriately.
Please find out from your warehouse/stockist/wholesalers/distributors whether bottles of this specific batch are available. If yes, get samples of bottles from there and find out such different coloured tablets are present in the packed bottles.
If you receive similar complaints for the same batch number from different customers then you may have to recall the specific batch from the market and inform FDA about this. Also, find out whether such mix-up has happened to other preceding and succeeding batches of the same product. And accordingly, please take CAPA actions.
These are the few multiple ways to investigate the complaint to find our exact root cause. Unless you find exact root cause you will not be able to take appropriate CAPA actions.

[sunilrbudhkar]

Here I have assumed that the different coloured tablet is of different product.
If the “Different coloured” tablet you referred to is of the same product due to “Discolouration” or “Degradation” then it is a stability issue or may be some different reason (of Isolated case).
Please clarify.