Dispensing of Raw Materials

 

Dispensing of Raw Materials 

1. BMR (Batch Manufacturing Record) is received from the Production department.

2. After receiving the BMR, check the approval status of all materials. If any material is under analysis, immediately inform QC for release.

3. Before dispensing, ensure that all required materials are available.

4. Transfer all materials to the “To Be Dispensed” storage area through the material entry room as per FEFO / FIFO.

5. Before entering the dispensing area, all personnel shall follow the secondary gowning procedure.

6. After entering the dispensing area, verify the area cleaning status.

7. Ensure the weighing balance is clean and daily verification status is completed.

8. Before starting dispensing, the store person shall verify:

Material code

AR No.

Manufacturing date

Expiry / Retest date

9. Switch ON the dispensing booth RLAF at least 15 minutes before starting dispensing.

10. Ensure differential pressure gauges are within limits:

Pre-filter: 1 – 6 mmWC

Intermediate filter: 3 – 6 mmWC

HEPA filter: 8 – 16 mmWC

11. Check and record dispensing area temperature and relative humidity.

12. Before starting dispensing, ensure scoops and containers are clean to avoid cross-contamination.

13. Obtain line clearance from QA before starting the dispensing activity.

14. During line clearance, if any discrepancy is observed, the QA person shall inform the QA Head.

15. After receiving QA line clearance, start the dispensing activity.

16. Dispense materials one by one under the RLAF safe zone.

17. After dispensing the material store person write the gross weight,net waight and tare weight on the dispensing label.

18. After dispensing, transfer the material to the Dispensed Material Storage Area.

19. Update loose quantity label and material transferred material staging area.

20. After completion of dispensing activity, close the documentation and hand over the dispensed materials to Production.

21. Production person check the gross weight and material name, manufacturing date and expaire date or retest date.

22. After completion of raw material dispensing, clean the dispensing area.

23. Upd

ate the dispensing area status.