Handling of Returned Goods SOP

SOP for Handling of returned goods | Handling of returned goods in pharma industry |

• SOP for Handling of returned goods covers below points:
  • Reasons of returned goods
  • Handling of returned goods procedure
  • Returned Goods Register format

1.0 OBJECTIVE :

• This SOP defines the procedure for Handling of Returned Goods.

2.0 SCOPE :

• This SOP is applicable for the handling of all the returned products from the market for any reason at the warehouse.

3.0 RESPONSIBILITY :

• Warehouse Head: To receive & store the returned products as per the instructions given by Quality Assurance Department.
• Quality Assurance Head: Overall responsible for receipt, storage, reprocessing or destruction of returned products.

4.0 ACCOUNTABILITY:

• Q.A. Head

5.0 PROCEDURE :

5.1 Finished Products are returned for various reasons from distributers/customer, but on exceptional cases.

5.2 Returned Goods Classification: Returned Goods received by the ware house shall be classified according to the following criteria.

• Date Expired Products/ Short Expiry (less residual life).
• Damaged or Broken Primary Containers.
• Mutilated or smudged labeling rendering the product un-identifiable of its Name, Batch No. Mfg. Date Exp. Date, also not complying the regulatory regulations or soiled label rendering the product un-presentable, although the product is clearly identified & also complying the regulatory requirements.
• Products recall, as directed by Health / Regulatory Authorities.
• Products recalled as per the advice of the business partners.

5.3 The product recall is carried out as per the Product Recall SOP.

5.4 Returned goods shall be accompanied with the Challan / Invoice along with the product withdrawal details form (Refer Product Recall SOP Annexure No. 03) of the concerned party.

5.5 The above said documents are checked by Quality Assurance Head or designee & if the details match with the Product Recall Circular (Refer Product Recall SOP Annexure No. 02), previously sent to party, then instruct to Quality Assurance officer to carry out the physical verification of the returned goods.

5.6 The physical verification & counting of the returned goods is done by Quality Assurance officer or above along with the Ware House officer.

5.7 If the physical verification & counting is matched with the Challan quantity & satisfactory, then only Quality Assurance Head or designee instruct the Ware House Head to receive the returned goods.

5.8 Chemical/Microbiological analysis may be carried out as per situation.

5.9 Handling :

• Transfer returned goods to “RECALLED GOODS” room. The necessary entry should be taken in Returned Goods Record (Refer Annexure No. 01). The key of the “Recalled Goods Store” is with Quality Assurance Head.
• Non confirming report is issued to the followings by Quality Assurance department indicating complete detail of product with total Quantity of receipt.
  • Director
  • Quality Assurance Head
  • Quality Control Head
  • Production Head
• Non confirming report is differentiated from other report by indicating and marking “Return”. These reports are kept by Quality Assurance, Quality Control and Receiving Departments.
• Quality Assurance department will inspect immediately for following categories of the returned goods.
  • No Defect: Return to inventory.
  • The product is defective or allegedly defective – Require Quality Control assessment and have to complete complaint report.
  • The product was damaged in transit, will require re-labeling, re-packing or rejection.
  • The Quality Control laboratory indicates the results of the assay and other characteristics and if acceptable then approve the material back to inventory.
  • If the drug product does not meet the applicable standards, it will be destroyed as per destruction procedure & take the necessary entry in the Destruction Record.
  • If the defects can be rectified such as repacking, relabeling then that shall be done after analysing the quality of the product by Quality Control departments and shall be replaced and dispatched.
  • Maintain the destruction record of the product.
• After completion of complete product recall, the returned products stock statement is to be submitted to local FDA.
• The final decision on the returned products is taken by recall team as per the returned products classification as mentioned above of this SOP.

5.10 Date Expired Product :

• Quality Assurance chemist or above shall check the products detail for their correctness that the Product is expired. If found expired, intimate the same to Quality Assurance Head & initiate the action for destruction. If the product is near to expiry date, he / she intimate the same to Quality Assurance Head & wait for instructions. Destruction is carried out by production personnel in presence of Quality Assurance chemist or above as per the destruction procedure & take the necessary entry in the Destruction Record.

5.11 Damaged or Broken Primary Containers :

• Damaged or Broken Primary Containers shall be examined by Quality Assurance officer or above. If the damage to the container is such that it does not expose the product to the atmosphere, the possibility of recovery could be considered. If the labeling is intact & the product on batch Identity is not affected, the product is to be recovered as per SOP (Refer Preparation of master formula record and master packing record) & take necessary entry in Log Book for Returned Goods Register.
• If the damage to the containers is such that the product is exposed to the atmosphere & contamination could result, then proceed for destruction.
• Destruction is carried out by production officer or above in presence of Quality Assurance chemist or above as per the destruction procedure & the necessary entry should be taken in the Destruction Record.

5.12 Mutilated or smudged labeling rendering the product un-identifiable of its Name, Batch No., Mfg. Date, Exp. Date, also not comply the regulatory regulations or Soiled label rendering the product un-presentable although the product is clearly identified & also complying the regulatory requirements:

• Returned products having mutilated or smudged labeling rendering the product un-identifiable of its Name, Batch No., Mfg. Date, Exp. Date, also not complying the regulatory regulations  shall be destroyed as per the destruction procedure & the necessary entry should be taken in the Destruction Record.
• For the Returned products having soiled label rendering the product un-presentable although the product is clearly identified & also complying the regulatory requirements, the possibility of recovery could be considered. If the labeling is intact & the product & batch identity is not affected, the product is to be recovered, repacked and sold/dispatched.

5.13 Products recalled as directed by local FDA or by the Health / Regulatory Authorities:

• Products recalled on the advice of the local FDA or by the Health / Regulatory Authorities should be handled as per product recall.
• Returned Products due to Class I type recall (Refer Product Recall SOP) shall be destroyed as per the destruction procedure & the necessary entry should be taken in the Destruction Record.
• Returned Products due to Class II type recall (Refer Product Recall SOP), after review from Quality Control & Quality Assurance department, if found not to be reprocessable shall be destroyed as per the Destruction procedure & the necessary entry should be taken in the Destruction Record.
• Returned Products due to Class III type recall (Refer Product Recall SOP), shall be recovered as per the recovery procedure.

5.14 Products recalled as per the advice of the Principal Company for which the products are manufactured:

• Products recalled as per the advice of the Principal Company for which the products are Manufactured shall be handled as per the Point No. 5.11 of this SOP.

 6.0 ABBREVIATIONS:

Abbreviation	Expanded form
SOP	Standard Operating Procedure
FDA	Food and Drug Administration
MFG	Manufacturing
EXP	Expiry

7.0 ANNEXURES:

Annexure No.	Title
01	Format for Returned Goods Register

8.0 SOP REFERENCES

• GMP Guidelines

END OF THE SOP

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ANNEXURES :

Annex. No. 01 Format for Returned Goods Register

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