Biomedical Engineering Reference
In-Depth Information
SOP No.:
Issued on:
Revision No.:
Initiator name:
Packaging, Qa (in-Process), and Qc documentation
s. no.
documents
dept.
yes
no
n/a
remarks
1.
Master packaging instruction is available and duly signed
(different consignees)
Packaging
2.
Packaging material requisition is attached and appropriately
filled and signed (different consignees)
Packaging
3.
Packaging checklist (Documents Compliance Declaration)
Packaging
4.
Batch packaging record # 1/addendum BPR
Packaging
5.
Time sheet for packaging (1st and 2nd shift)
Packaging
6.
Batch packaging record for hand packing (if applicable)
Packaging
7.
Printing requisition, line clearance, and reconciliation for
labels
Packaging
8.
Printing requisition, line clearance, and reconciliation for
boxes
Packaging
9.
Reconciliation of leaflets
Packaging
10.
First signed coded labels, boxes, leaflets
Packaging
11.
First and last signed label from each used label roll
available
Packaging
12.
Area/equipment/line clearance (packaging and maintenance
department) is attached and properly filled for line
no._______
Packaging
13.
Output sheet is available and duly filled and signed
Packaging
14.
Area/equipment cleaning status labels (different stages)
Packaging
15.
Packaging reports and release of finished product
Packaging
16.
Documents compliance declaration
Packaging
17.
Finished product checklist
QA
18.
Inspection start-up checklist with release label (each
consignee)
QA
19.
QA in-process final packaging record (each consignee)
QA
20.
Analytical report for finished product (each consignee)
QC
Any other documents
Audited by:
Date:
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