Biomedical Engineering Reference
In-Depth Information
Attachment Vi
SOP No.: QAS-002
Revision No.:
Issued on:
Initiator sign:
Packaging Area Documents
Check the:
1. Batch packaging record for the presence,
correctness of all the entries, and the
correctness of manufacturing and expiry
dates as per the shelf-life
2. Batch packaging record for
a.
Blister packing
b.
Hand packing line (if applicable)
c.
Bottle torque (if applicable) that if the
tablet is container pack
3. Packaging report or release of finished
product (for different consignee)
4. Packaging materials requisition
5. Batch yield final and at various in-process
stage is correct
6. Rejection verification at various stages of
processing and at final stage
7. Reconciliation of labels and boxes done by
the packaging department
8. Area/equipment line clearance for packaging
operation
9. MPI for different consignee
10. Output sheet
11. Repacking Addendum
12. Store requisition for the repacking material
Reviewed by:
Page 5 of 7
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