My product target yield range was 70-144 kg, but i’m getting the weight around 165 Kg, How to justify this. Shall i recommend lab experiments followed validation? The process was validated.
Since the process was validated, I suspect very much a human error. Are the weights of the major ingredients right ? Were processing steps correctly followed ? Processing stFull testing is needed. The yield cannot be left unexplained. If it is the case, maybe you’re missing process parameters.
I agree wholeheartedly. This sounds like a faulty batch.
Not sure what product is could uptake of moisture in process increase your weight?
Generally product batch yield limits are decided based on Process validation batches. Since your process is validated then please let me know following,
How many batched did you manufacture after process validation was conducted?
What is the trend of yield obtained in all the batches produced after process validation?
How many batches were out of the limit for yield?
Did you make any major changes in the master formula, process etc?
Please check theoretical yield against KSM (Key starting Material) .If actual yield is more than theoretical yield then it clearly says that it may be Moisture content (check LOD ) or other Inorganic matrial not completely wash out / Unreacted Raw material (Check Assay of Product) if you taking proper starting Batch Raw Material ,Always remember that actual yield never more than theoretical yield.
(Regarding : API and its Intermediates )