Dispatch the product to Market

Dear Experts

I have one doubt regarding the dispatches. Pl clarify

In R&D product was developed. From R&D product was transferred to the plant directly without pilot batches. We have manufactured the one trial and three validation batches. Can we supply these batches material to customers if not for what type of purpose this material can be used. If we supply this material to customers any pre-intimation to be given to customer or not.

Pl provide the support guidelines also for justifying the above



In that case you can sell your product after complete the validation process. if i am not wrong your trial batch purpose would be to ensure the process developed in R&D at production level. There would be two cases in this scenario…

  1. If trial batch was confirmed according to Your R&D process at production level then you can use the same process for validation in order to prove the process consistency at least with 3 batches. After complete the validation process those batches shall be loaded for stability. You can sell the product with at least 3 months stability along supporting stability data initiated at R&D level… In this case you can use R&D batches stability for assign the Retest date.
  2. IF trial batch was having problems which may significant process changes required then once again your process will be at initial stage. So you needs to look back at R&D process and shall be improve the process and sort out the problems arose during the trial batch execution. So you needs to wait for sell this batch until completion the process validation… If any small changes which may not impact on the product quality If API Increasing of solvent ration which are using as a media to react the material, temperature at non critical step if justified, Vacuum during the distillation and drying process.

Finally you can sell out product after completion of the process validation without further question if that process is validated. That material can be used at customer end for their uses and they will take further action, if you are a new vendor then they will be put their effort to fulfill the all requirements cited in their internal procedures. If you are the existing vendor then your change control system will have the Option for intimate the changes details if it is modified process. Other wise you needs to intimate to the customer that you are going supplying the material with modified process or new route of synthesis…

Pulla Reddy Karnati