SOP for Product Recall

1. OBJECTIVE
To lay down the procedure to deal with the recall, field corrections, market withdrawals and stock recoveries

2. SCOPE
This SOP shall be applicable to the withdrawal of the product from the market.

3. RESPONSIBILITY
• Executive Director – For Approval of recall.
• Site Quality Head – For Investigation and recommendation for recall.
• Head of manufacturing – To investigate the reason jointly with site quality head.
• Head of Marketing – To monitor and follow up the recall

4. SAFETY INSTRUCTIONS
• N/A

5. PROCEDURE

5.1 Any product complaint from consumer, field staff or from Drug Control Authority is referred to Quality Assurance for investigation.
5.2 After completion of investigation and evaluations QA manager shall be informed to initiate the recall.
5.3 Based on evaluation the class of recall will be decided.
5.4 Notification to quality head shall include the following information:
5.4.1 Complete identity of the product and accurate explanation of the reasons for taking the action.
5.4.2 Date of the action to be completed.
5.4.3 Evaluation of the potential risks.
5.4.4 Quantities of the product for recall.
5.4.5 Level of recall.
5.4.6 Extent of Drug Control involvement.
5.4.7 Any special problems, considerations, complexities etc.
5.4.8 Financial implication of action.
5.4.9 Recommendation for preventive action.
5.5 Site quality head will notify local Drug Control Authorities in case if level of recall, recall initiated on instruction/ advice from drugs control Administration.
5.6 Head of Marketing and distribution shall be informed about the recall and necessary product information. He will stop further distribution and give clear directions to this effect to all key points in the distribution.
5.7 Recall communication shall also seek and obtain information on socks of product which is being recalled and confirmation that further distribution and sale has been stopped and such stocks are quarantined, by deputing a person to all depots, Stockiest, Chemists and Hospitals depending upon the level of recall.
5.8 If the product defect is CLASS I, the drug has to be withdrawn by sending, intimation up to customer level by making the public announcement using media and memorandum to all distributors, Stockiest and Hospitals, Chemists and Customers, if addresses available with bill.
5.9 Head of Marketing/ Distribution will check whether the information has reached to all concerned by making telephone personnel’s visit to concerned location.
5.10 If the product defect is CLASS II intimation has to be sent to distributors and field staff. Distributors are asked to discontinue the sale of product batch. All the field staff shall be informed to collect the stocks concerned from Hospitals/ Chemists/ Dealers under their area and to return the withdrawn stocks to concerned distribution center.
5.11 If the product defect is CLASS III, recall the product from distribution outlets and stockiest.
5.12 Entire stocks of the material, which have to be recalled, shall be collected to warehouse and shall be held under strict security.
5.13 Where appropriate, stock shall be held till inspection formalities by Drug Authority/ Insurance Company/ Excise Authority are completed.
5.14 Site Quality head shall instruct the Warehouse Manager where the material has to be transferred for disposal.
5.15 Destruction shall be carried out under the supervision of production and QA Department representatives.
5.16 Record of such destruction shall be maintained for a period six month beyond the stated expiry date.

6. RELATED DOCUMENTS
Recall Assessment Form – Annex. I
Recall Log – Annex. II
Recall Letters/ Notice to Distributors/Marketing Company/Retailers – Annex. III

7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.

8. ABBREVIATIONS
Q.A Quality Assurance Department

9. REVISION HISTORY