1.Objective :

To lay down the procedure for handling of returned goods from distributor / customer end.

2. Scope:

This procedure is applicable for identifying, holding and/or disposition of Drugs Product & Drug Substances returned from distributors and / or customers.

3. Responsibilities

QA, QC, Marketing, Warehouse, Production

4. Definitions:

  • Returned Goods: The material which has been returned in case they do not meet their acceptance criteria or has been returned on the basis of breakage / damaged packaging, commercial or administrative aspects or on the basis of customer complaint investigation and action thereof.

5. Procedure:

  • Returned goods shall be received, identified and stored in separate pallets in the designated area by warehouse person with the identification label as “Returned Goods” & shall be stored as per appropriate storage conditions of respective product.
  • Warehouse person shall check following points against dispatch documents and documents received from the distributor / customer inspect the consignment & shall record the observation in Returned Goods Verification Report. Now, this report shall be sent to QA.

Batch Identification Number

Authenticity of Labels

Number of Drums Received against supplied Drums

Drums Condition , intactness & seal integrity

Cleaning of Consignment

Weight of Individual Drum

Total Quantity

Identity of Product
  • QA person shall verify the returned consignment against following parameters but not limited to,

-Meeting with its physical parameters

-Seal is broken or intact

-Seal number and label number is matching with packing details

-In case returned goods having specific storage condition, whether it was maintained or not.

  • If the seal is broken by the customer, the material shall be sampled from each container and analyzed.
  • Based on satisfactory evaluation against specification, decision of release shall be taken & material can be sent for re-sale.
  • If results are on border line / out of specification limit then material shall be rejected and investigation shall be carried out.
  • In case the material is about to expire, then the same shall be analyzed for the identification test and shall be taken for the appropriate reprocessing.
  • If the material is found to be contaminated, then it shall be sent for destruction/disposal.
  • Based on the finding & analytical results of returned goods, QA shall recommend the action for Re-processing/Repacking/Disposition or distribution for sale or for destruction as per Recommendations on Returned Goods and shall forward the same to Production or Warehouse for further action.
  • Manufacturing and expiry date of returned goods shall remain unchanged.
  • QA shall maintain record for returned goods along with its complete set of documents.

Label for Returned Goods

RETURNED GOODS
Sales Return no. : ———————–  
Product Name : ———————–  
Batch No. : ———————–
Date of Return : ———————–
Net wt. : ———————–
Cont. No. : ———————–  
  1. Abbreviations :
  • QA : Quality Assurance
  • QC : Quality Control

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