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Standard Operating Procedure (SOP) for Handling of Returned Goods Pharmaceutical Product/Material. These returned goods (materials) either fails to meet the established Specification or returned on the basis of breakage / damaged packaging.

Handling of Return Goods (Drug Product / Material)

1.0   PURPOSE:

• • The purpose of this SOP is to define the procedure for handling, redressing, and repacking of finished goods/ returned goods.

2.0   SCOPE:

• • This procedure is applicable for handling, redressing, and repacking of finished goods due to revised price, shelf life extension, (conversion of sale pack to physician’s sample pack or vice versa) and returned goods, returned from any other location/Market.

3.0   REFERENCES:

• • In-house

• • SOP for Handling of Rejected Material in Manufacturing Area.

• • SOP for Clearance of lines, Area and Equipment’s

4.0   RESPONSIBILITIES – HANDLING OF RETURNED GOODS:

• • Warehouse (BSR) personnel shall inform to Quality Assurance & Production department about the receipt of returned finished goods and maintain the records of returned goods.

• • Warehouse (BSR) personnel shall check all the documents and conditions of return goods and shall store the returned goods as per the recommended condition.

• • Quality Assurance personnel shall verify the physical condition of return goods and ensure that the laydown procedure is followed as per SOP.

• • QA personnel shall provide BPR in case of Redressing/Repacking of finished goods/ returned goods and shall withdraw the Control Sample, and release the batch after the completion of all packing activities.

• • Quality Control personnel shall analyze returned goods as per recommendation by QA Head.

• • Production personnel shall plan for packing as per the action suggested by QA Head and shall generate BOM, work order, and MRO as per the requirement.

• • The plant Head and Quality Head shall be responsible for the review and approval of the SOP and to ensure the compliance of this laydown procedure.

5.0   ABBREVIATIONS – HANDLING OF RETURNED GOODS:

• • BOM: Bill Of Material

• • BSR: Bonded Store Room

• • BPR: Batch Packing Record

• • COA: Certificate Of Analysis

• • GIM: Goods Inward Memo

• • DEFINITIONS:

• • Returned Goods:

• • The material which fails to meet the established Specification, at the customer’s end or the material which does not meet the customer’s specification.

• • The material, which 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.

• • Withdrawal of specific batch/batches from the market, based on Product Recall procedure.

• • Re-Dressing:

• • It is defined as repacking of the drug substance without disturbing its original inner bag (Primary packing material) by only changing its label or outer drum (secondary packing material) for commercial purpose.

6.0   PROCEDURE – HANDLING OF RETURNED GOODS:

• • Receipt and handling of returned goods:

• • Warehouse (BSR) personnel shall receive the returned goods from the market or any other location.

• • Store the materials on separate pallets as per the appropriate storage condition of the respective products in the designated area of return goods or in the other area by identifying with blue rope/net (if space is not available in the designated area).

• • After receipt of the material, the warehouse shall verify the returned consignment for the following points against receipt documents received.

• • • Identity of the product / Authenticity of labels.

• • • Batch Number

• • • The number of Containers/Shippers received against supply.

• • • Condition of Containers/Shipper’s intactness and seal integrity.

• • • Weight and the total quantity of returned goods Containers/Shippers.

• • Warehouse personnel shall check the physical condition of returned goods and record the details in the “Returned Goods Verification Report”, Annexure-1.

• • Warehouse personnel shall generate “Distribution Receipt” and prepare a GIM in the system on the basis of originally acknowledged challan, and confirm the system generated “Goods Returned Settlement Memo”.

• • In case of any discrepancy in the receipt documents, Warehouse shall not confirm the “Goods Returned Settlement Memo” and intimate to concern person/ customer/ marketing department/ other location, for its rectification.

• • After rectification of discrepancy in receipt documents warehouse shall confirm the “Goods Returned Settlement Memo” in the system.

• • After the generation of “Distribution Receipt” in the system and physical verification of returned goods,

• • Warehouse personnel shall send the “Returned Goods Verification Report” Anexxure-1, to the QA for verification.

• • QA shall verify the goods consignment and shall recommend for decision-based on the following:-

• • • If, the material is returned due to commercial dispute or due to not meeting with physical parameters;

• • • In case if the material is found intact, the seal number and label number are matching with packing details, then the decision shall be taken by management to release the material for re-sale directly.

• • • If, the material is returned from the customer on the commercial dispute or due to not meeting with physical parameters, or the seal is broken by the customer,

• • • QA shall verify the material and based on observation, the decision shall be taken as per Annexure-1.

• • • If the material is found to be contaminated or if it is the case of sabotage, the same shall be sent for destruction/disposal as per Annexure-1.

• • After completion of physical verification of return goods by warehouse and QA,

• • The Warehouse shall ensure cleaning and/or de-cartooning or redressing (In case of Shipper) of the returned goods as per the condition required.

• • Warehouse personnel shall print “Returned Goods Quarantine label” Annexure-2 and shall affix it on each container, based on the recommendation of the Production Head and QA Head as per the Annexure-1.

• • Note: Returned Goods-Quarantine labels shall not be required to affix on the returned container if it is decided to discard the materials.

• • QA personnel shall fill the “Returned Goods Verification Report” Annexure-1 and forward it to Production Head and QA Head for its recommendation.

• • Based on the recommendation of the “Returned Goods Verification Report” Annexure-1, return goods are allowed for sampling and reanalysis.

• • After reanalysis, if the result complies with the specification limit, then materials shall be released for re-sale after redressing /re-packing.

• • If it is failing to meet the specification limit, then material shall be discarded as per decision Annexure-1.

• • Based on the recommendation of the Production Head and QA Head.

• • QA personnel shall forward the “Returned Goods Verification Report” Annexure-1.

• • QC, in case it is recommended for sampling and reanalysis.

• • Packing, in case sampling and reanalysis are not required and material shall directly pack.

• • Warehouse (BSR) in case material is recommended for disposal.

• • QC Shall generate QC order in the system for sampling and retesting if materials are recommended for reanalysis.

• • QC shall make the entry in Return Goods Verification Report Anexxure-1 & shall perform sampling and re-testing of returned goods.

• • On completion of reanalysis, QC shall ‘Approve’ or ‘Reject’ the material, as appropriate, in system & shall submit all the above documents along-with the analytical documents to QA for further decision.

• • Based on the finding & analytical results of the material, QA shall recommend the action for Redressing/Repacking/Destruction as per annexure-1.

• • In the case of sampling and retesting not required of returned goods and it is allowed for Redressing/Repacking directly,

• • Then QA shall forward the Returned Goods Verification Report Anexxure-1 to the packing department directly.

• • In case if it is decided to reprocess the goods, then it shall be handled through the SOP of “Reprocessing” and the Manufacturing and Expiry date of goods shall remain unchanged.

• • The final disposition of the returned goods shall have to be finalized within 60 days of receipt.

• • In case if it is decided to Disposal the Returned goods, then it shall be disposed of as per the SOP “Handling of Rejected Material in Manufacturing Area”.

• • Redressing of Return Goods:

• • Packing personnel shall generate the redressing record request after the receipt of Return Goods Verification Report Annexure-1 from the QA department.

• • Packing personnel shall collect the returned goods from the warehouse (BSR) and store it at an appropriate place before its packing operation.

• • QA shall issue the authorized batch redressing record after verifying Mfg. Date and Exp. Date.

• • Make necessary entries in the same register where previous entry of the same batch is addressed for the issuance.

• • The packing officer shall start the commencement of redressing activity after receipt of the batch redressing record.

• • Packing personnel shall take the line clearance of area and equipment.

• • It shall be recorded in batch redressing records.

• • The packing officer and QA officer shall perform the in-process check during the redressing activity.

• • Record the same in the batch redressing record.

• • After completion of the redressing activity, the QA officer shall withdraw the Control Sample and ensure complete documentation of the batch redressing record.

• • After closing of batch redressing record, the QA officer shall fill the final inspection report Annexure-1 &

• • • If found satisfactory shall release the batch for dispatch.

• • • For any discrepancy found during FP inspection, it shall be discussed with the QA head and corrective action shall be taken as per the recommendation of the QA head.

• • QA shall check and review the redressing record and release the batch.

• • Repacking of Return Goods:

• • After the receipt of the Return Goods Verification Report Annexure-1 from the QA department,

• • Packing personnel shall collect the returned goods from the warehouse (BSR) and

• • Store it at the appropriate place before its packing operation.

• • Re-packed finished goods shall be assigned batch number which will be suffixed with “R”.

• • All the packed returned goods shall be defoiled in the environmental controlled area and after defoiling of packed returned goods;

• • Packing and QA personnel shall jointly verify the physical condition of defoiled goods for it’s repacking.

• • On the basis of the physical condition of defoiled goods,

• • QA shall examine the bulk for appearance and decide whether it shall be packed/ discarded.

• • If the physical conditions of defoiled goods are not satisfactory

• • Then it shall be allowed for disposal as per the annexure-1.

• • If the physical condition of defoiled goods is satisfactory and it is decided to pack the defoiled goods.

• • Then packing personnel shall raise a request to the QA department for issuance of batch packing record.

• • QA shall withdraw the sample and send to QC for analysis purpose along with test requisition cum report if required.

• • All the defoiled goods containers/carat shall be store in packing quarantine /appropriate place till its commencement of packing activity, with proper status labeling.

• • If bulk goods are transferred to the quarantine area then it shall be recorded in the quarantine Inward/Outward Logbook.

• • QA officer shall issue the authorized batch packing record after verifying Mfg. Date and Exp. Date.

• • Make necessary entries in the same register where previous entry of the same batch is addressed for the issuance.

  • The packing officer shall start the commencement of repacking activity after receipt of the batch packing record.

  • Packing personnel shall take the line clearance of area and equipment as per the Sop.

• • It shall be recorded in the batch packing record.

• • The packing officer and QA officer shall perform the in-process check during the repacking activity,

• • Record the same in the batch packing record.

• • After completion of the repacking activity.

• • QA shall ensure complete documentation in the batch packing record and withdraw Control Sample.

• • After completion of the packing operation Return Goods Verification Report Anexxure-1.

• • The analytical docket shall be attached with BPR.

• • The warehouse shall fill the details in the “Returned goods logbook” as per Annexure-3.

7.0   ANNEXURES – HANDLING OF RETURNED GOODS:

Annexure-1 Returned Goods Verification Record

Date___________

• Warehouse (BSR):                          

Name of the Product			Batch No.
Mfg. Date:			Exp. Date
Dispatch STN No.			STN/ Dispatch Date
Quantity Dispatched			Date of Return Receipt
Wt. of Return Qty. (Wherever Applicable)			Quantity Received (No.)
Total No of Container			Label Authenticity
Seal No. (If any)			Seal Integrity	OK / Not OK
Goods Return from
Reasons for Returning
Conditions of  Returned Goods
Any other observations
Documents handed over to QA

Done by (Warehouse-BSR)	Checked by (Warehouse-BSR)
Name:	Name:
Sign:	Sign:

• Quality Assurance:

  • Physical Verification of Returned Goods and Its observations:-

• • On the basis of physical verification, the recommendation shall be given as:-

To be Packed		Not To be Packed
Condition	Recommendation	Condition	Recommendation
Sampling and retesting Required	Yes/ No	Product condition is not satisfactory	write off
Only Redressing is Required	Yes/ No	Product  Shelf life is less than Six Months	write off
Repacking to be done without  retesting	Yes/ No	Quantity is very less	write off
Any Other		Any Other

Reason for Recommendation:-

Remarks:-

Recommended by (Production/Packing Head)	Recommended by (QA Head)
Name:	Name:
Sign:	Sign:

•  Quality Control:

Name of the Product		Batch No.
Mfg. Date:		Exp. Date

 

Sr. No.	Test	Finish product Analysis Result	Retest Analysis	% deviation from the Previous Result	Remarks (Comply/ Not comply)
1
2
3
4
5

• Quality Assurance:

• • Based on the review of the documents and analytical data of returned goods, the product is recommended for Redressing/Repacking/ writes off.

Recommended by  (Quality Assurance)	Approved By (QA Head)
Name:	Name:
Sign:	Sign:

• Packing:

Product Name		Batch No.
Materials Receipt from Warehouse (BSR) on		Quantity receipt from the warehouse (BSR)
Packing Started on		Packing completed on
BPR Closed on		Date of BSR Transfer
Qty. Transferred to BSR		Total No. of Shipper Transferred

Approval (Only in case if the batch is to be discarded)
Approved By (Quality Head)	Approved By (Plant Head)
Name:	Name:
Sign:	Sign:

Annexure-2 Returned Goods Quarantine Label

Sales Return No.	:
Product Name	:
Batch No.	:
Date of Return	:
Net wt.	:
Cont. No.	:
Sign./Date (Warehouse)	:

Annexure-3 Returned Goods Log Book

Sr. No.	Product Name	Batch No.	Mfg.	Exp.	Hold Month*	Date of Receipt/ Return

Bulk Material return from	Return Qty.	Proposed Action As per Annexure-1	Date of Dispatch/ Reject	Qty. Dispatch/ Reject	Closure	Remarks

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