Procedure of recovery of granules from previous batches

What is the procedure of pharmaceutical granules recovery?

Please note the following aspects,

  • Granules or left over tablets from previous batches can be recovered by adding to next batch/es at dry mixing / granulation / lubrication stage as appropriate.
  • The quantity of granules / crushed tablets should be not more than 10% of the total batch size in to which these are to be added. (generally followed by the companies)
  • Expiry date of the batch to which these granules are added should be the expiry date of oldest batch of granules added.
  • It is to be ensured that the granules / tablets to be added to the fresh batch must be approved by QC/QA.
    -The entire procedure should be goverend by internal SOP.
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