1. OBJECTIVE
To describe the procedure about the packing of bulk tablets.
2. SCOPE
The procedure is applicable for packing of bulk tablets.
3. RESPONSIBILITY
Operator: To follow as per the written down procedure.
Packing Supervisor: To monitor and execute the written down procedure.
Head of Department: Implementation of the procedure
4. DEFINITIONS:
Nil
5. REFERENCES.
S.O.P. Guidelines
6. PROCEDURE
6.1. Before starting the packing, the packing area shall be checked for proper cleaning.
6.2. Obtain line clearance from QA for starting of packing.
6.3. Only one product shall be taken for packing at a time.
6.4. Check that the labels on the bulk containers for the Product Name, Batch Number etc., is
matching with the printed packing materials.
6.5. Ensure the approval of bulk tablets from Quality Control.
6.6. Check that all packing materials issued are approved by Quality Control.
6.7. The packing area shall have a status label containing Product Name, Batch Number,
Manufacturing Date and Batch Size.
6.8. Packing supervisor shall be instructed to check whether the personnel involved in the
packing area are properly wearing nose masks, hand gloves, Head caps etc.,
6.9. Before packing the tablets are to be dedusted and inspected. Counted tablets are
collected in poly bags and sealed immediately.
6.10. Sealed poly bags are packed in jars along with all the packaging materials like packing
insert, Silicagel, Tagger seal etc., or follow the instructions as per the Batch
Manufacturing Record.
6.11. Close the jars with the lid
6.12. Jars are labeled with the approved labels.
6.13. Labeled jars are put in the corrugated shipper, seal it with the BOPP tape and label the
shipper accordingly.
6.14. Quality Assurance chemist shall check randomly quantity and quality of the tablets packed
in a jar.
6.15. All packaging materials issued are as per the packing materials indent and reconciled and
details are recorded in the BMR.
7. RECORD :
Batch Manufacturing Record
8. Revision History
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