Purchase Return Process – Standard Operating Procedure

1) Purpose

To establish a standardized procedure for managing the return of purchased goods that are defective, damaged, or otherwise unacceptable, ensuring compliance with contractual agreements and regulatory requirements within the pharmaceutical purchase department.

2) Scope

This SOP applies to all returns of purchased goods, including raw materials, packaging materials, and other supplies, within the pharmaceutical purchase department.

3) Responsibilities

Procurement Manager: Responsible for overseeing the return process and coordinating with suppliers.
Procurement Team: Responsible for initiating returns, documenting return requests, and communicating with suppliers.
Quality Control (QC) Team: Responsible for inspecting returned goods and providing necessary documentation for the return process.

4) Procedure

4.1) Identification of Goods to be Returned:
4.1.1) Identify goods that need to be returned due to defects, damages, or non-compliance with specifications.
4.1.2) Document the reasons for the return, including detailed descriptions of defects or issues.

4.2) Initiating the Return Process:
4.2.1) Notify the supplier of the intent to return goods and provide detailed information about the issues identified.
4.2.2) Obtain authorization from the supplier to return the goods, including any required return authorization numbers.

4.3) Preparing Goods for Return:
4.3.1) Segregate and label goods to be returned, ensuring they are clearly identified.
4.3.2) Package the goods appropriately to prevent further damage during transit.
4.3.3) Include all relevant documentation, such as return authorization forms, invoices, and inspection reports, with the returned goods.

4.4) Shipping the Returned Goods:
4.4.1) Arrange for the return shipment in coordination with the supplier, including selecting the appropriate shipping method.
4.4.2) Track the shipment to ensure it reaches the supplier and obtain confirmation of receipt.

4.5) Documentation and Record Keeping:
4.5.1) Maintain records of all returned goods, including return authorization numbers, shipment details, and confirmation of receipt by the supplier.
4.5.2) Document any credit notes or replacements provided by the supplier as a result of the return.

4.6) Follow-Up and Resolution:
4.6.1) Follow up with the supplier to ensure that the return is processed and resolved in a timely manner.
4.6.2) Address any disputes or discrepancies with the supplier to ensure a satisfactory resolution.
4.6.3) Update inventory records and financial accounts to reflect the return and any credits or adjustments.

5) Abbreviations, if any

• QC: Quality Control

6) Documents, if any

• Return Authorization Forms
• Inspection Reports
• Shipping Records
• Confirmation of Receipt
• Credit Notes

7) Reference, if any

Regulatory Guidelines: FDA CFR Part 211, GMP Guidelines
Industry Standards: Best practices in return management

8) SOP Version

Version 1.0