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.
Thank you for your response.
Thanks. You are most welcome…