Standard Operating Procedure for Handling Returned Goods in Tablet Manufacturing

Department	Tablet
SOP No.	SOP/TAB/199/2025
Supersedes	SOP/TAB/199/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To define the procedure for handling returned goods in tablet manufacturing, ensuring that all returned products are appropriately managed to maintain product integrity and comply with regulatory requirements.

2. Scope

This SOP applies to the handling, inspection, and documentation of returned goods in tablet manufacturing. It includes both finished products returned due to defects or customer complaints and raw materials returned due to quality issues or overstock.

3. Responsibilities

• Quality Assurance (QA): Responsible for overseeing the process of handling returned goods, ensuring that all returned products are inspected, documented, and assessed for quality compliance.
• Warehouse Team: Responsible for receiving, segregating, and labeling returned goods, ensuring that the returned items are stored appropriately for further evaluation.
• Production Team: Responsible for investigating the cause of the return and ensuring that any non-conformance is addressed, including corrective and preventive actions (CAPA) (Annexure-1).
• Regulatory Affairs: Ensures that the handling of returned goods complies with applicable regulatory guidelines and industry standards.

4. Accountability

The QA Manager is accountable for ensuring that the process for handling returned goods is followed in compliance with regulatory requirements. The Production Manager is accountable for ensuring that returned products are inspected and evaluated to determine if they can be reused or need to be discarded.

5. Procedure

5.1 Receiving Returned Goods

1. When returned goods are received, immediately segregate them from other products to avoid any cross-contamination.
2. Verify the reason for return by reviewing the return documentation or customer complaint records. All returns must be accompanied by a return authorization form (Annexure-2).
3. Label all returned goods with the “Return” label, indicating the reason for return, batch number, and the date of receipt.
4. Ensure that all returned products are placed in a designated quarantine area until further evaluation.

5.2 Inspection and Evaluation of Returned Goods

1. Inspect all returned goods for visible defects or damages. If the returned goods are finished products, check for signs of damage, contamination, or expiry.
2. For finished tablets, verify that the batch number and expiration date match the return documentation (Annexure-3).
3. If returned raw materials are received, check the integrity of the packaging, the batch number, and the expiry date. Ensure the materials have not been tampered with or exposed to environmental factors (e.g., temperature or humidity) that could affect their quality.
4. For returned goods, review the product history to determine if the product can be reused, reworked, or needs to be discarded based on its condition and the cause of the return.

5.3 Documentation and Record Keeping

1. Document all returned goods, including the batch number, the quantity returned, the reason for return, and the action taken (rejection, reuse, or rework) in the Return Goods Log (Annexure-4).
2. Ensure that all inspection results, corrective actions, and approvals are recorded in the Return Goods Evaluation Log (Annexure-5).
3. Maintain records of the return authorization form, inspection results, and any communications regarding the return for traceability and future reference.

5.4 Action on Returned Goods

1. If the returned goods are finished products and cannot be reworked or resold, they must be disposed of in accordance with regulatory guidelines for the disposal of pharmaceutical products.
2. If the returned goods are raw materials, assess whether they can be returned to inventory for use in future production. Ensure that the material is properly requalified before it is reused.
3. If the returned goods can be reworked, create a rework plan, including a description of the process, equipment, and personnel involved, and ensure that the rework process complies with GMP guidelines (Annexure-6).
4. If returned goods are defective and cannot be reused or reworked, ensure that they are properly disposed of following the disposal guidelines and regulatory requirements.

5.5 Corrective Actions and Preventive Actions (CAPA)

1. If returned goods are found to be defective, investigate the root cause of the issue and document the findings in the CAPA Log (Annexure-7).
2. Implement corrective actions to resolve the root cause of the defect, such as process improvements, equipment maintenance, or staff training.
3. Implement preventive actions to prevent the recurrence of similar issues with future production batches.

5.6 Disposal of Returned Goods

1. For returned goods that cannot be reworked or reused, ensure proper disposal in accordance with environmental regulations and local disposal guidelines for pharmaceutical products.
2. Document all disposal activities, including the reason for disposal, the method of disposal, and the date, in the Disposal Log (Annexure-8).

5.7 Compliance Monitoring

1. Conduct periodic reviews of the return goods handling process to ensure compliance with regulatory requirements and internal SOPs.
2. Track and review any trends or recurring issues with returned goods to identify areas for improvement in the manufacturing, packaging, or quality control processes.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• GMP: Good Manufacturing Practice
• CAPA: Corrective and Preventive Action
• API: Active Pharmaceutical Ingredient

7. Documents

1. Return Goods Log (Annexure-4)
2. Return Goods Evaluation Log (Annexure-5)
3. Rework Plan (Annexure-6)
4. CAPA Log (Annexure-7)
5. Disposal Log (Annexure-8)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• ISO 9001 – Quality Management Systems
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Return Goods Inspection Report

Material Name	Batch Number	Reason for Return	Inspection Results	Action Taken
Tablet A	Batch-12345	Defective packaging	No damage found	Returned to inventory

Annexure-2: Return Authorization Form

Return ID	Material Name	Batch Number	Reason for Return	Return Date
RMA-12345	Tablet A	Batch-12345	Customer complaint	01/03/2026

Annexure-3: Material Return Evaluation Log

Batch Number	Material Name	Evaluation Result	Action Taken
Batch-12345	Tablet A	Pass	Reworked

Annexure-4: Return Goods Documentation Log

Return ID	Batch Number	Action Taken	Return Date
RMA-12345	Batch-12345	Returned to inventory	01/03/2026

Annexure-5: Disposal Log

Return ID	Material Name	Disposal Date	Disposal Method
RMA-12345	Tablet A	02/03/2026	Incineration

Annexure-6: CAPA Log

Action ID	Action Description	Responsible Person	Completion Date
CAPA-001	Investigated customer complaints	Jane Smith	01/05/2026

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated return procedures	Improved handling of returned materials	QA Head