Return Of Goods SOP

1.0              PURPOSE:

To lay down the procedure for to be handling of ‘’Return of finish good’’.

2.0              SCOPE:

This SOP is applicable to all the goods returned to ----------------------------

3.0              RESPONSIBILITY:

3.1              FG store is responsible for receipt of return goods and intimate to Plant Head/QA HOD

3.2              Quality Assurance department responsible for investigate the goods and record the investigation report.

3.3              Plant Head/QA HOD responsible for take action plain as per investigation report and return goods procedure.  

4.0              ACCOUNTABILITY:                       

The accountability lies upon Quality Assurance Head & Plant Head for the implementation and complies of the SOP.

5.0              PROCEDURE:          

5.1              Finish good store receipt the returned goods it shall be stored in an area marked for “Returned Goods” in Bonded Store Room (BSR). And if the goods have been returned against recall it shall be stored in area marked as “Recalled Product”. If the goods have been returned due to Product Recall, then it shall be treated as per SOP No. SOP-QA-021.

5.2              In case of returned Goods, BSR Personnel shall fill the Returned Goods Log Format No. F/QA-021-01 with details like Sr. No., Date of return, Name of Party, Product Name, Batch No., Quantity received after reprocess, Dispatch Quantity and Invoice No.  Remarks if any.

5.3              The BSR Personnel shall then fill the Returned Goods Form Format No. F/QA-021-02 with Product details like Name, Batch No., Mfg. Date, Exp. Date, Returned by (Name) and address, Reason for return and send it to Quality Assurance as intimation.

5.4              The Quality Assurance Officer shall then go and investigate the goods and record the investigation report.

5.4.1        No Defect – Goods shall be returned to manufacturing.

5.4.2        Short Expiry or if the drug product does not meet the standard – Goods shall be destroyed as per SOP.

5.4.3        Goods are damaged in transit – Sample shall be sent for reanalysis and on receipt of confirmatory report, goods shall be returned to manufacturing for repacking.

5.5              Final authorization for destruction or reprocessing shall be given by Quality Assurance HOD/Plant Head.

5.6              If the product is reprocessed then, when it shall be dispatched and record maintained in the same.

6.0              LIST OF ANNEXURE AND FORMATS:    

Sr. No.	Title of Format	Format No.
01	Returned Goods Log	F/QA-021-01
02	Returned Goods Form	F/QA-021-02

 

 

 

 

7.0              REFERENCES:

7.1              SOP-QA-001

7.2              F/QA-001-01

7.3              SOP-QA-014

7.4              SOP-QA-035

 

 

8.0              REVISION HISTORY:   

Sr. No.	Date	Reason for Revision	Revision No
1.	31/10/2018	New SOP	R0
2.	31/10/2020	Schedule Revision	R1

 

9.0              ABBREVIATIONS:

Sr. No	Abbreviations	Details
	MFG.DATE	Manufacturing Date
	EXP.DATE	Expiry Date
	Sr. No.	Serial Number
	BSR	Bonded Store Room
	SOP	Standard operating procedure

 

 

 

 

 

 

 

 

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