Yield Increased, how to justify

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.

1 Like

I agree wholeheartedly. This sounds like a faulty batch.

1 Like

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?

2 Likes

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 )

2 Likes

Exactly sir…

There are so many factors affecting the batch output yield. Some cases are defined below.

  1. Check the Input quantities of batch raw materials.
  2. Check the in-process controls whether within the limits or not.
  3. If the batch manufacturing product is optically active compound, check the quality of the input KSM.
  4. Whether batch output quality meeting all the acceptance criteria.
  5. If the output product is optically active compound, check whether it complies SOR test.
  6. Check whether all the critical process parameters are maintained as defined in the batch manufacturing record.
  7. During the manufacturing of the optical active products, if there are any variations in reaction mass pH and temperature maintenance and time duration shows the impact on the batch output quality.
  8. If there are any variations in above case, unwanted isomer compound also gets isolated along with required products.

This topic was automatically closed 10 days after the last reply. New replies are no longer allowed.