Procedure For  handling of returned goods

by

 STANDARD OPERATING PROCEDURE

Title: Procedure For  handling of returned goods

  • OBJECTIVE
    •  To lay down a procedure for handling of returned goods.
  • SCOPE
    • This procedure is applicable for handling the retuned goods.
  • RESPONSIBILITY
    • Manager-Quality Control
    • Manager-Warehouse
  • ACCOUNTABILITY
    • Manager-Quality Assurance
  • PROCEDURE
    • Returned goods in general belongs to:
      • Recalled product in-case of product recall.
      • Returned saleable finished goods.
      • Returned, damaged, non-salable finished goods.
    • Procedure for recalled product.
      • Warehouse shall receive the recalled goods & store in a separated area. Affix the status label “Market Recalled Product” on all packs/shippers.
      • Dispose the product after getting approval from Manager-Quality Assurance.
      • Destroy the recalled product as per SOP (Title: Handling of Rejected Material) and document.
  •       Procedure for returned salable/non-salable finished goods.
      • Warehouse shall receive the return goods and keep in separate area for returned goods in finished goods warehouse.
      • Label all Container /Packs with status label “Market Returned Product”
      • Enter details of returned product in “Returned Material Intimation Register”.
      • Intimate Quality Assurance regarding the returned goods.
      • QA Investigation procedure for Returned, Non-salable Finished Goods.
  • On receipt of intimation of returned goods QA shall initiate a joint inspection with QC.
      • Manager-QC shall assess the investigation findings and discuss with Manager-QA and decide the status.
      • Material which are found not confirming to the specifications will be rejected and considered as non-salable finished goods
      • Based on the investigation and assessment Manager-Quality Assurance shall decide the disposition the material and declare as Non-saleable Finished goods.
      • QA to affix status label indicating “NON-SALABLE FINISHED GOODS” on all containers / packs.
      • Obtain permission from Central excise for destruction of such non-saleable finished goods and completion of excise rules.
      • During destruction, the product shall be separated from the primary packing compound and destroyed by Chemical /Physical means (Dissolve in water/solvent etc.). The removed primary packing compound along with secondary packing materials shall be destroyed by shredding, incineration as applicable.
      • The resulting slurry obtained by destruction of pharmaceutical dosage form shall be treated as effluent and salvaged.
      • Goods are destructed in presence of Personnel from Central Excise, Warehouse & QA.
      • Update the concerned excise documents.
      • Record the whole investigation finding, destruction mode and details as per “Investigation Report for Material Returned, Damaged, Non-salable Finished Goods”
  • QA Investigation procedure for Returned, Re-saleable Finished Goods.
    • On receipt of intimation of returned goods QA to coordinate with QC for inspection and testing of the returned goods and initiate for joint investigation.
    • Manager-QC shall decide the sample quantity, tests required as per the status / reason for return of the material. However all critical tests (viz., Assay, Dissolution, pH, Moisture content etc. as applicable) shall be performed and assessed for compliance to product specifications.
    • Manager-QC shall assess the inspection and test status and give his opinion / recommendation to Manager-Quality Assurance for final evaluation.
    • The joint investigation shall include details of control samples, review of the particular batch record and justify reason for return.
    • Finally Manager-QA shall approve, based on the investigation finding, the returned goods as “salable finished goods”.
    • QA shall affix status label indicating “SALEABLE FINISHED GOODS” on all containers/ packs.
    • Transfer the material from Returned good area to finished good storage area and arrange.
    • QA to recommend the quantity of finished goods for dispatch as such and quantity required a repacking before dispatch.
    • In-case of material is to be diverted from export return to domestic market; same is dispatched after repacking by production followed by QC release & QA Approval.
    • Document all such repacking activities.
    • Account the quantity of saleable finished goods to BSR quantity.
    • Based on the intimation for dispatch of goods received from marketing the goods are dispatched. Remove the status label “SALEABLE FINISHED GOODS” while dispatch.
    • Enter the dispatched quantity in respective registers & update the concern excise documents.
    •   Record the investigation finding, repacking details as per “Investigation Report Material Returned, Re-salable Finished Goods / Products”.
  • ABBREVIATIONS
    • QA –  Quality Assurance
    • SOP –  Standard Operating Procedure
  •     FORMAT

         Nil

  •      DISTRIBUTION LIST
    • Quality Assurance
    • Quality Control
    • Warehouse