Biomedical Engineering Reference
In-Depth Information
Attachment IV
SOP No.: QCS:
Issued on:
Revision No.:
Initiator name:
CHECKLIST FOR THE BATCH DOCUMENT AUDIT
(Packaging Area Documents)
1. Batch packaging record for the presence, correctness of all the entries,
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and the correctness of manufacturing and expiry dates as per shelf life.
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2. Packaging materials requisition (computer copy).
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3. Batch yield, final, and at various in-process stage is correct.
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4. Rejection verification at various stages of processing and at final stage.
5. Reconciliation of labels, leaflets, and boxes done by the
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packaging department.
6. Area/equipment line clearance for packaging operation along with machine
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cleaning status label.
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7. Master packaging instructions for different consignee.
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8. Output sheet.
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9. Repacking addendum (if applicable).
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10. Store requisition for the repacking material.
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11. First and last label of each roll of the product to be included in the batch file.
12. Batch packaging record for
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a. Blister packing
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b. Suppositories filling and packing
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c. Liquid filling and packing
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d. Powder filling and packing
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e. Bottle packing (tablet/capsule)
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f. Bottle torque (if applicable)
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g. Sachet filling and packing
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h. Hand packing (if applicable)
Any other documents
Reviewed by:
Applicable & available =
Applicable not available =
?
=
Not applicable
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