SOP for receipt and handling of return goods

1.0 OBJECTIVE:

To describe the procedure for receipt, accounting and handling of returned goods

2.0 SCOPE:

This Standard Operating Procedure (SOP) covers the procedure of receiving the returned goods manufactured & dispatched from [Company Name] Location. The goods may be returned from [company name]. godown in Mumbai for commercial reason or for quality reason or other reason from within India or from foreign customers to Finish Goods Store (FGS) at [company name]

3.0 RESPONSIBILITY:

3.1 Finished Goods Stores (FGS) Personnel:

To verify the details of the return goods

To intimate QA department for any goods receipt.

3.2 QA Personnel

To verify the details of goods returned

To conduct investigation If required.

3.3 QC Personnel :

To analyse the sample and report the same (On need based).

3.4 Head QA:

To ensure the compliance of this SOP.

3.5 Production Head

To review of document related to return goods on requirement bases.

Handling of Return goods during Redressing or re packing

4.0 PROCEDURE:

4.1 Receive the intimation from distribution, Export, Shipping department and Depot regarding the goods that are expected back to location through email or fax or through Telephonic talk.

4.2 Security personnel shall intimate concern FGS personnel for arrival of the goods at the gate.

4.3 Concern FGS personnel shall identify the return goods / products by checking the documents of the material and check the details like Product name, Label potency of Drug product, Batch No., Quantity, and subsequently check for the damage, Intactness of packaging. 

4.4 Returns can be Due to incorrect deliveries, ordered in excess, damaged in transit, nearing the end of shelf life, etc.

4.5 If checking found satisfactory Unload the returned goods at dispatch bay on HDPE pallets (batch wise).

4.6 Document the details as per Annexure-I with the reason for return.

4.7 Records of the returned goods shall be maintained along with all relevant documents.

4.8 Inform Head QA or his designee regarding receipt of the returned goods as per annexure-I. QA personnel shall inspect the returned goods for the details mentioned and further (to ensure the doubt about safety, identity, strength, quality or purity of drug product) same shall be verified by Head QA and account for the breakage / missed quantity (if any), reason for return, etc.

4.9 Further the FGS personnel shall enter the required details in the Register for Returned Goods as per Annexure-II.

4.10 The return goods shall be stored in returned goods area under Lock and Key.

4.11 If the reason for drug product being returned implicates associated batches, an appropriate investigation shall be conducted.

4.12 Make the entry for receipt of returned goods in the prescribed excise register prevailing at the time of receipt.

4.13 Inform central excise authority as per the rule prevailing at the time of receipt of returned goods.

4.14 Get the returned goods duly verified from central excise officials as per the law prevailing at the time of receipt.

4.15 On the basis of information gathered QA head shall prepare action plan on return goods, in regard to ensure the safety, identity, strength, quality and purity of the drug product. This may include (Need based)

4.15.1 Analysis of sample.

4.15.2 Review of storage condition under which returned drug products have been held, Specific storage condition (if any)

4.15.3 Review of Condition of drug product, show box, labeling

4.15.4 Potential for tampering.

4.16 The action plan and findings shall be review by Production Head and QA head and decide for redressing, reprocess, repackaging, destruction or any other by these committee. 

4.17 Copy of Report of the committee shall be addressed to the Corporate Quality Assurance (CQA) for their information otherwise ask comments in the matter of goods to be rejected.

4.18 If the material to be redressed/repacking the operation is carried out in concern area. Additional sheets of required shall be issued and records to be attached with batch record.

4.19 Repacked goods shall undergo for required analysis and release procedure.

4.20 If the goods is to be destroyed at site, apply to excise authority for permission to destroy, it is to be destroyed as per following procedure.

4.20.1 Collect all the cartons, leaflet, shadowbox & place aside separately and cut, in case of strips and blister Defoil or de-blister and keep empty strips and blister aside and tablets/capsules other side in separate drums with double line poly bags or only in poly bags with proper label. Incase of bottle deface the label to loss the identity of label and collect the tablets/capsules other side in separate drums with double line poly bags or only in poly bags with proper label.

4.20.2 Send the printed packaging material for shredding to concern area.

4.20.3 Send the tablets/ capsules for destruction/disposition to Effluent treatment plant (ETP) with proper labeling including detail such as “Product name”, “Weights” & “Area” etc.

4.21 A complete report shall be prepared by production head and approved by QA head and photo copy of same shall be forwarded to CQA, production, FGS (for further action on requirement basis) and original copy shall retain with Batch record.

4.22 Repacked goods (primary packaging) shall be kept for accelerated stability study for six month.

4.23 Controlled sample shall be collected from repacked goods (primary packaging).

5. ANNEXURE:

Annexure I: Returned Goods Intimation and Investigation

Annexure II: Register for Returned Goods

Annexure I: Returned Goods Intimation and Investigation

Report of Return Goods 

Form: Finished Goods Store

To: QA Department

Product Name 

Batch No

Mfg. Date

Exp. Date

Qty. Received

Shortage if any

Received From: 

Reason For Return:

Related documents available:

Verified By: (FGS)

Verifying the condition of goods return.

1 Condition of Secondary Packing:

2 Condition of Primary packing:

3 Condition of Drugs (Approved):

4 Details on Shippers:

5 Details on Labels:

6 Details on strips / blisters / bottles:

7 Any other observation: 

Above mentioned documents Verified and found satisfactory / not satisfactory.

FGS Dept.

QA Dept.

Action Taken: 

1. Perform following analysis on sample of return goods:

2. Verifying the documents like BMR/BPR/analytical report

3. Details of Incidents / Deviation / OOS / CCP during manufacturing.

4. Details of personnel involved in manufacturing /packaging and analysis.

5. Review on storage condition. Before goods dispatched and in transit / goods return.

6. Stability record of same batch or other batches of same product.

7. Outcome of Annual Product review.

8. Any Other.

Head QA

Findings on Action Plan:

Head QA

Conclusion:

QA Head

Production Head

Comments of Corporate Quality Assurance (If require):

Corrective Action:

Head QA

Closing Status

Head QA

Annexure II: Register for Returned Goods

Sr. No

Name of the Product/ Strength

Mfg. Date

Exp. Date

Batch No.

Quantity received

Reason for the Goods return

Checked By Sign / Date (FGS)

Verified By Sign / Date (QA)

Quantity Transfer to Production Department (If required)

Other Quantity Transferred (If required)

Quantity Repacked Redressed (If any)

Disposition or other (if any)

Sign / Date (FGS)

Sign / Date (QA)

Remark