Procedure For  handling of returned goods

 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