Biomedical Engineering Reference
In-Depth Information
SOP No.:
Issued on:
Revision No.:
Initiator name:
annexure vii
QUALITY ASSURANCE DEPARTMENT
BATCH DOCUMENTS CHECKLIST
(FOR PARENTERAL PRODUCTS)
Product:
Code No.:
Mfg.:
Batch No.:
Expiry:
manufacturing, Qa (in-Process), and Qc documentation
s. no.
documents
dept.
yes
no
n/a
remarks
1.
Documents Compliance Declaration
Prod.
2.
Approved Master Formula and Method (MFM) is
available, properly filled and signed on each
manufacturing step
Prod.
3.
Batch manufacturing record # 1 and packaging
material requisition (for ampoules, vials, rubber
stoppers, or flip off seals)
Prod.
4.
Drug weighing area/equipment clearance checklist
with cleaning status label
Prod.
5.
Raw material weighing record with weighed material
printouts with daily weight check for balances
printout
Prod.
6.
Inspection start-up checklist
Prod.
7.
Area/equipment clearance checklist for each stage/area
with release label and equipment cleaning status label
Prod.
8.
SIP prints for mobile tank
Prod.
9.
Mobile tank vent filter integrity printout
Prod.
10.
WFI temperature, conductivity, and pH monitoring
printout
Prod.
11.
WFI printout for each manufacturing stage and final
weight printout of bulk solution
Prod.
12.
Stoppers sterilization chart (if required)
Prod.
13.
Filtration assemblies/machine parts/gowning
sterilization chart
Prod.
14.
Prefilter integrity test printouts (before and after)
Prod.
continued
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