STANDARD OPERATING PROCEDURE PRODUCT RECALL

STANDARD OPERATING PROCEDURE

SUBJECT:                      PRODUCT RECALL

DEPARTMENT           : QA SOP NO.                      : Page No                       : Effective Date             : Next Review                : SOP REVISION           :

1.0       OBJECTIVE:

Batch Recall from the market due to various problem during its shelf life, change in Physical or Chemical properties of the product. The following procedure is followed for the Recall of the Batch from the market.

2.0       POLICY: 

To ensure establish a procedure for product recall.

           

3.0       PROCEDURE:

3.1       The Batch number of the Product is identified by Q.A and informed to the Principle representative.

3.2          Dispatch details are collected and sent to the Principle representative who will communicate with the distributors to collect the unsold stocks of the batch and send to the warehouse.

3.3       The Finished goods warehouse Executive shall receive the stock in area in the finished goods stores and label accordingly. The returned goods will be stored in a segregated area away from regular products as per the required storage condition in a restricted area.

3.4       On receipt of the stock, the matter is communicated to the G.M (Q.A) and the Production Manager who shall take necessary action.

3.5       The matter is reported to the Govt. officials concerned if required.

3.6       Incase of the loan license, the Product will be recalled as per the instructions given by the Parent company necessary information or documents will be produced to the Parent company to recall the Products.

3.7       The sample of the recalled product is drawn and tested as per the approved testing procedure and copy of COA in shared with the principal company.

3.8       Action is planned based on the decision or conformation of the principal company.

4.0       FREQUENCY:  As and when required.

                       

5.0       RESPONSIBILITY: Q.A Dept., Production Dept., Warehouse.

6.0       REVIEW GUIDE:  Product Recall records.

6.0         ANNEXURE: 1. Returned goods log sheet.

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	√
Warehouse	x	x
General	x	x
Maintenance	x	x