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.

• 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, a decision of release shall be taken & material can be sent for re-sale.
• If results are on borderline / 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.
• The manufacturing and expiry date of returned goods shall remain unchanged.
• QA shall maintain a record for returned goods along with its complete set of documents.

Label for Returned Goods

1. Abbreviations :

• QA : Quality Assurance
• QC : Quality Control

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