PURPOSE: 

To lay down the procedure  and methods for reconciliation of issued material and returning of the material left unused, responsibility for implementation the procedure and records to be maintained for conformity with GMP requirements

RESPONSIBILITY  : The Production Supervisor.

                                    The Production Manager.

                                    The Quality Assurance Officer.

PROCEDURE:       

1.Remove the used and unused material from the work station at the end of last batch

operation.

2. Remove the wasted, rejected material from the work station at the end of last batch operation.

3.Count or weigh all of the removed material.

4.Record and account for all the material in reconciliation sheet.

5. Investigate any significant or unusual discrepancy observed during reconciliation of the quantity of material issued and number of units produced.

6. Inform the in-process assurance supervisor for verification of destruction of wasted material and excess coded material.  Record the destruction in log.

7. Prepare the material return note in duplicate. Specify the reason of return.

8. Get the authorization of production manager and permission of quality assurance officer for material return.

9. Return the material in store and receive the acknowledgement in the duplicate copy.

10. Attach the acknowledged copy in the batch product record and complete the reconciliation

                        (Review date on or before 12 months from date of authorization)