Standard Operating Procedure for Handling of Recalled and Returned Finished Goods in pharmaceuticals

1. Purpose:

To provide a standard operating procedure for handling Recalled and Returned Finished Goods in the pharmaceuticals.

2. Scope

The scope of this SOP is applicable for the Handling of Recalled and Returned Finished Goods in the pharmaceuticals at [company name].

3. Responsibility

Warehouse person: To receive the returned material and store it in the designated area as per procedure, inform the warehouse head, operations head, and QA head.

Operations head and QA head: To analyze the condition and make an appropriate decision under the purview of QMS

4. Definitions

Not applicable

5. Procedure

5.1 Handling of returned finished goods:

• Finished goods can be returned to the factory premises for various reasons, such as cancellation of fright, transportation issue, cancellation of the order, any commercial, or because of a product recall.

• On receipt of returned goods, the warehouse person shall inform to QA person. The warehouse person and QA person shall inspect the goods and the vehicle to verify the condition of goods and the vehicle for any abnormality. The details shall be recorded in Returned/ Recalled goods receipt and inspection report.

• In case the product is returned for any reason other than product quality issue, the returned product shall be stored in the finished goods area with appropriate labeling and segregation.

• The material shall be stored as per labeled storage conditions.

• Responsible person for handling legal matter shall inform the applicable government authority as per the law of the land (as applicable).

• In case of returned finished goods because of a product recall, it shall be handled as per the procedure for handling recalled goods (as per section 5.2).

• Warehouse person shall update the returned goods entry in the applicable logbooks and update the details in the material management software.

• Operations and quality assurance departments will prepare an impact assessment report.

• The returned goods can either be returned to the same customer, redressed and supplied to another customer, or destroyed.

• In case the product needs to be sent to the same customer, it shall be sent to the customer based on the impact assessment report concussion.

• In case of any other decision (except product needs to be sent to the same customer), the operations department needs to handle the proposal through the applicable Quality Management Tool (preferably temporary change control).

• Requirement of redressing, quality testing, and other impacted activity shall be assessed through the temporary change control.

• In case of the product be destroyed, the operations department needs to initiate the product destruction proposal.

5.2 Handling of recalled finished goods:

• Finished goods can be recalled back in the factory premises for various reasons, packing defect, storage issue, quality complaint, regulatory authority recommendation because of any regulation

• The decision and execution of recalls are handled by SOP for drug product recall. The scope of this SOP is to inward the recalled goods, storage, and destruction after completion of the required investigation.

• Recalled material should be stored in the designated area to store rejected/ recalled goods.

• Warehouse person shall check and receive the recalled material, relevant documents, investigation, and then it will be transferred to the designated area to store recalled material.

• Warehouse person and QA person shall inspect the goods and vehicle to verify the condition of goods and vehicle for any abnormality. The details shall be recorded in Returned/ Recalled goods receipt and inspection report.

• Warehouse person shall inform the QA department about the receipt of return goods. Responsible person for handling legal matter shall inform the applicable government authority as per the law of the land (as applicable).

• Once the investigation and other legal procedures are completed, the QA department shall guide to warehouse person about material disposition.

• Once the decision is made to destroy the material, the warehouse department shall initiate the material destruction note, QA department, operations department, and other applicable departments [approval authority will vary depending on organizations’ policy] will review the report. The plant head and quality assurance head will approve the destruction report.

• Destruction can be done in-house or with the help of an approved third party. In case of an authorized third party is used, a certificate of destruction must be maintained.

6. Frequency

The procedure is applicable for every return/ recalled goods.

7. Formats

7.1 Returned/ recalled goods inward logbook [logbook content]

Sr. No.

Date

Material/ Product Name

Batch No.

Manufacturing Date

Expiry Date

Goods Return from [Exact place from where the goods returned]

Customer/ Distributor name

Reason for Return/ Recall

Quantity of Returned/ Recalled Goods

Transportation Condition

Material Storage Condition

Material received by (Sign/ date)

Verified by warehouse head (Sign/ date)

QA person (Sign/ date)

7.2 Returned/ Recalled goods receipt and inspection report [logbook content]