Handling of Return Goods in Pharmaceuticals Plant

Standard Operating Procedure of Handling of Return Goods in Pharmaceuticals Plant is describe in this post.

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1. Purpose:

1.1. To ensure proper receipt, handling and disposal of return goods from Customers.

2. Scope:

2.1. This procedure applies to handling of returned finished goods from whole sale or retail distributors.

3. Responsibilities:

3.1. Quality Control Manager.

3.2. Quality Assurance Manager.

3.3. Production Manager.

3.4. Inventory Control Manager.

3.5. Marketing Manager.

4. Procedure:

4.1. The distributors/ Marketing Department Representative fill out RGR (Return Goods Report) describing the following and send to Marketing along with Bilty Form (TR).

• Product Returned

• Product Batch number

• Pack size

• Number of units Returned

• Reason for Return

• Transporter Name

• Transporter’s Receipt number (T.R. No.)

4.2. Marketing department send the above forms to the Inventory Control at the Plant.

4.3. The Inventory Control Manager receives the Rejected & Returned Products along with the form.    Count carefully in the presence of person carrying the product with quantities mentioned in Returned goods form and acknowledge by filling the same form, and note down the particular in the Rejected & Returned Products Log. The Inventory Control Manager, if find any discrepancy will note down in the form and keep one copy of same form in his record.

4.4. Segregation of Rejected & Returned Products:

4.4.1. After receipt of the Rejected & Returned Products the Inventory Control Manager immediately informs the designated Quality Assurance Officer.

4.4.2. The designated Quality Assurance Officer preliminarily inspects the Rejected & Returned product and get the Rejected & Returned product sorted out in terms of product identification and quantity through Inventory Control Officer and notes down the particulars in the Returned Product Segregation Log.

4.5. In case of Re-packing (the expiry date of product should be more than six month on the Rejected & Returned Product), Quality Assurance Officer prepares 2 copies of Re-Pack Advice Note duly signed by the Quality Control Manager. The designated Quality Assurance Officer issues reference number to the Re-Pack advice Note in Re-Process / Re-Pack / Destruction Advice Log and sends one copy to the Production Manager and the second copy is kept in Quality Assurance Department. Production Manager asks the concerned production officer to get all the label, unit carton and outer cartons stamped.

4.6. In case of Destruction (expiry date of the product should be less than six months on the Rejected & Returned Products), Quality Assurance Officer prepares 2 copies of Destruction Note duly signed by the Quality Control Manager. The designated Quality Control Officer issues reference number to the Destruction Note in Re-Process / Re-Pack / Destruction Log and sends one copy to the Incharge Rejected & Returned Product Store and the second copy is kept in Quality Control Department.

4.7. Processing of Products:

4.7.1. After receipt of the Re-Pack Advice Note the Production Manager asks the concerned Production Officer to collect Rejected & Returned products from the Store.

4.7.2. The concerned Production Officer collects the Rejected & Returned Products and signs both copies of the Re-Pack Advice Note and gives back the counter copy to the designated Quality Control Officer.

4.7.3. In case of destruction Advice Note, the designated Quality Control Officer arranges disposal of the Rejected & Returned Products with Inventory Control Manager.

4.7.4. Quality Control Officer fills out office use portion of RGR form in triplicate. The form is reviewed and verified by Plant Manager then forwarded to Marketing Department for processing the claim. One copy of RGR and NCR      F-07-009 is retained in QC records.

4.7.5. Return Goods received as a result of Product Recall are handled. 

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