SOP on Product Recalls

1.0 Purpose: This SOP defines the procedure for the recall of a failed drug product batch.

2.0 Scope: This SOP applies to all failed drug product batch. 

3.0 Responsibility: Quality Assurance Manager to ensure that the procedure is followed.

4.0 Materials and Equipment: None.

5.0 Procedure: Upon receiving complaints when a product is to be recalled, immediately take the following necessary steps – 

a. Freeze the internal stock of the product.

b. All competent authorities like distributors, wholesalers etc. should be informed about the seriousness of detect and intention to recall the product.

c. Establish the record and report of recalled product.

d. Organize the return of the recalled product.

     When a product is recalled from the market, the following details should be recorded – 

01. Serial number assigned to the returned goods.

02. Name and quantity of the product recalled.

03. Quantity recovered.

04. Reason for recall.

05. The cause of defects, if known.

06. The nature of the risk, if some patients are at risk, advice as to how they should be managed.

07. Organization of return of the defective product.

08. Addresses and telephone numbers of distributors, wholesalers etc.

Progress of recall process should be recorded from time to time and subsequently a final report should be issued including reconciliation between the quantities in hand, distributed and recovered. Recalled product should be stored in secured segregated area till its fate is decided.