STANDARD OPERATING PROCEDURE FOR PACKING OF BLISTERS/STRIPS

1. PROCEDURE:

To describe the procedure for packing of Blisters/strips.

2. SCOPE:

The procedure is applicable for secondary packing of blister/strips.

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 Ensure previous batch materials are removed from the area.

6.3 Obtain line clearance from QA before starting of the packing.

6.4 Only one product shall be taken for the packing at a time.

6.5 Obtain approval for blisters/strips from the quality control.

6.6 Check that all packing material issued, are approved by the quality control.

6.7 Overprinted packing materials are subjected to 100% inspection for the correction of Batch No, Mfg Date, Exp. Date details.

6.8 Check that the Blister/Strips for the Product Name, Batch Number, Manufacturing Date and Expiry Date are matching with the printed material.

6.9 Blisters/Strips are to be checked manually for the defects like  missed tablet / capsule, broken tablet / capsule, spotted tablet / capsule or smudged printing etc.,

6.10 Good Blisters/Strips are packed in cartons along with inserts or any other materials wherever it is applicable and counter checked by weighing simultaneously.

6.11Pack the cartons in a corrugated shipper, seal it with a BOPP tape and label the shipper accordingly.

6.12 Quality assurance chemist shall check randomly quantity and quality of the tablets packed in a carton.

7. RECORD:     Batch Manufacturing Record.

8. REVISION HISTORY: