Beruflich Dokumente
Kultur Dokumente
Disiapkan Oleh :
Prepared By
Disetujui Oleh :
Approved By
Disetujui Oleh :
Approved By
Disetujui Oleh :
Approved By
Disetujui Oleh :
Approved By
Tanggal
Date
Tanggal
Date
Tanggal
Date
Tanggal
Date
Tanggal
Date
Disetujui Oleh :
Approved By
Tanggal
Date
Batches Manufactured
Material
Batches
No.
Manufactured
Batches
Released
[List all batches that were reworked or reprocessed during the review period, including a
description of the steps taken to rework or reprocessing and the procedure number used
(Table 3-2)]
Table 3-2
Rework or Reprocessing
Description of the
Material Material
Batch
Procedure
Rework/ Reprocess
Name
No.
No.
Reference
Operation
Material Deviation
Status Reference
Audit Status
Materia
l Name
Materia
l No.
Manufacture
r Name
Manufacture
r
Status
Audit
Statu
s
Number
of
batches
Receive
d
Number
Of
Bathes
Released
Number
of
Pending
Release
Number
of Bathes
Rejected
Document Code
Implementation Date
Remark
Actual Results
Remark
Result of
Control Chart
Table 5-5
Process Capability Analysis (IPC Results)
No. Test
Specification
Control Limit Cp
Cpk PPM
Parameter Limit (LSL & USL) (LCL & UCL) value value total
Table 5-6
Remark
Sigma
value
Remark
Result of
Control Chart
Remark
Table 5-7
No.
Test
Specification Limit Control Limit
Parameter (LSL & USL)
(LCL & UCL)
Cp
Cpk PPM Sigma Remark
value value total value
Stabilities Studies
Material Name
Table 5-9
No.
Stability
Program
Table 5-10
No.
Condition
Specification
Control Limit Result of
Remark
Limit (LSL & USL) (LCL & UCL) Control Chart
Stability
Test
Specification Limit Control Limit Cp
Cpk PPM Sigma
Remark
Program Parameter
( (LSL&USL)
(LCL&UCL) value value total value
Confirmed/
Uncorfimed
Reference to
Deviation No.
Root
Cause
CAPA
Status
7. Deviations
[List all critical and not critical deviations (Table 6-1)]
Table 6-1
No.
Material
Name
Material No.
Batch
No.
Critically
Local
Number of
Defect
(Critical/
Batch No. Deviations
Type
Non-critical)
[For all critical and non-critical deviations, provide a short description, root cause and CAPA
(Table 6-2)]
Table 6-2
Critical Deviations
Table 6-3
Root Cause
CAPA
Status of Deviation
Report
CAPA
Status of Deviation
Report
Non-Critical Deviations
Root Cause
Status Remark
Short Description
Date of Approval
Status Remark
Short Description
Date of Approval
Status Remark
Short Description
Date of Approval
Status Remark
9. Validation Review
[All validation activities performed during the review period must be listed (Table 10-1),
including the reason, batch and reference to the validation report, it includes details of any
process validation activities performed during the review period (manufacturing processes,
cleaning procedures, laboratory methods, reason for revalidation and results of validation)]
Table 8-1
Process Step
Status
Equipment/ Utility
ID
Equipment
Qualification
Status
Change/
Deviation
Next
Qualification
Quality Agreement
Name of Contractor/
Reference
Sandoz Affiliates
Remark
The review of the site documentation against registration dossiers was performed and the
gaps identified are being remediated via change control system]
Table 11-1
Manufacturi
Description of
Description
Packaging
Shelf
Analytical
ng Site
Location
Location
Manufacturing
Location of Process
Site
Life
Test Site
Name
Process
Controls
[All information regarding submitted, granted or refused marketing authorizations and postmarketing commitments for new marketing authorizations and variations to marketing
authorizations should be listed. The DRA is responsible to provide input regarding submitted,
granted or refused marketing authorizations and variations there of]
12. Complaints
12.1
Technical Complaints
[List all technical complaints during the review period. Conclusion made as a result of the
investigation should be included (Table 12-1). Medical complaints which results in technical
complaint evaluation are included in the overall list and summary]
Table 12-1
Batch
No.
Short
Root
CAPA
Description Cause
Conclusion
Returned Products
[List any returned drug products. The list should include the batch number and reason for
returning, investigation and final decision and also corrective and preventive action which
had been done (Table 13-1)]
Table 13-1
Batch No.
Reason
[List any batches withdrawals or recalls, along with the reason for recall or withdrawal (Table
13-2)]
Table 13-2
Summary of Recalls
Batch No.
CAPA PIan
Action Descriptions
17. Annexes
18. Distribution
PIC
Due Date