SOP for Handling of Returned Material/Products

PURPOSE

To Lay down systematic procedures to establish handling of returned material/ products from the market.

SCOPE

This method is applicable for handling returned material/products from the market.

RESPONSIBILITY

Production Head

Tech. Director

Head Quality Assurance

ACCOUNTABILITY

Head Quality Assurance

PROCEDURE

• Any material or goods (Finished products &/or intermediates) returned from the market shall be stored in a separate area dedicated to storing returned goods.
• Record all the details in the Returned Goods Record, as per Annexure II.

• Inform the Quality Assurance department for evaluation of the returned goods.
• The Quality Assurance chemist shall evaluate the returned goods for the following:

1. Check the COA and other documents with the returned consignment.
2. Condition of the Packaging, carton, and container.
3. Labeling details.

ALSO READ: SOP for Rework/Reprocessing Procedure

• If the returned materials have exceeded the labeled expiry period &/or the condition of the packaging, carton, container, and storage condition of the material before returning/ shipping are doubtful, then destroy the material as per the SOP for control sample destruction.
• If none of the above conditions is apparent, then sample the material as per the SOP for sampling the Finished Products.
• Analyze the sample as per the currently approved product specification. Suppose the product meets the appropriate product specification. In that case, the returned material/ product may be considered for reprocessing as per the SOP for reprocessing, provided the subsequent product meets the product specification.
• In case the sample fails to meet the product specification, destroy the material/product as per the SOP for destruction, and initiate a failure investigation.
• Identify the batches manufactured during the same period &/or manufactured by using the same RM’s. Extend the investigation to these batches also.
• Refer flow chart for the handling of the returned material/ products as per Annexure I.

REFERENCES

NIL

ANNEXURES

Annexure I - FLOW CHART OF HANDLING OF RETURNED MATERIAL/PRODUCT

Annexure II - RETURNED MATERIAL/ PRODUCT RECORD

ABBREVIATIONS

SOP: Standard Operating Procedure

QA: Quality Assurance

COA: Certificate of Analysis

FG: Finished good

REVISION HISTORY

Nil

ALSO READ: SOP for Complaint Handling Process