Standard Operating Procedure For Handling Of Returned Products

by Pharmadocx Consultants


To lay down the procedure and methods to handle the product returned to

warehouse for any reason, its disposition, responsibility for implementation of the

procedure and records to be maintained.


The Commercial Officer.

The Quality Assurance Officer.

The Production Manager.


1.  Isolate the returned products in a restricted area and identify indicating the details of

the consignment and reason for return.

2.  Inform the quality assurance department to assess whether the consignment is to be destroyed or reprocessed for distribution or sale.

3.Classify the returned product on basis of:

a)  Date expired product.

  • Damaged or broken primary container
  • Multilated or smudged labeling of its name or batch number.

Soiled labeling rendering the product un-salable or un-presentable on the shop shelves but otherwise identifiable

4. Take authorisation in writing from quality assurance department for destruction of:

  1. The date expired product
  2. Unidentifiable product
  3. Product with damaged or broken primary container
  4. Product unsuitable for redressing.

5. Carry out the destruction under supervision of committee comprising quality assurance, production and commercial department personnel.

6. Empty out the contents of individual containers of product to be destroyed.  Collect the content in a vessel containing water.  Label the vessel.  Drain in mains before effluent treatment plant.

7. Obliterate the printing on printed packaging material and crush.

8. Remove the labels from emptied out product container by submerging in a bin containing water. Collect the peeled off labels, cut and crush.

9. Get instructions in writing from quality assurance department for re-dressing (re-labeling) of identifiable intact product with sufficient shelf life.

10. Inform the concerned production department to arrange for redressing of returned product in accordance with instructions given by quality assurance department.

11. Carry out the redressing in an isolated area under supervision without changing the product details.

12. Get the product tested as per finished product specifications.

13. Return the redressed product to finished good store after approval from quality assurance department.

14. Record the details of destruction or redressing action.

Author: (GM Production)Checked by: (QA Manager)Authorised by: (Director Technical)
Date:Date :Date :

                        (Review date on or before 12 months from date of authorization)

Written by Anmol Singh

Anmol Singh Completed his Bachelors in Field of Mechanical and Automation Engineering. He has over 2 Years of experience in field of Pharmaceuticals, Medical Devices, Cosmetics Manufacturing.

11 June 2023

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