Product Quality Review

[Product Name Dosage Strength Dosage Form]

N PQR_XXX_YYYY
Period: DD/MM/YYYY - DD/MM/YYYY

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

Product Quality Review

[Product Name Dosage Strength Dosage Form]
1. Corrections
[Only applicable for subsequent version in case an error is noticed or additional
information becomes available after approval and distribution]
2. General Information
[Provide a short synopsis of the report contain the product description, the manufacturing
site, and the review period]
[Rationale why the review period has been shortened or extended]
3. Executive summary
[Summarize the outcome of the review including corrective actions from previous reports
that were implemented in this review period, any significant issues or changes reported
in this reporting period. There should be a clear statement on the current status of the
product regarding the status of control, process capability and state of compliance]
4. Batches manufactured
[List of all batches manufactured, released, pending release, and numbers including
failed batches/rejections during the review period for specific product. Gaps in batch
numbering, e.g. due to validation lots pending approval or orders are cancelled before
any production commenced, must be explained in detail (Table 3-D]
Table 3-1
Material
Name

Batches Manufactured
Material
Batches
No.
Manufactured

Batches
Released

Batches Pending Batches

Release
Rejected

[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

[Describe the production process flow diagram]

Material Deviation
Status Reference

Product Quality Review

[Product Name Dosage Strength Dosage Form]
5. Starting Materials and Vendor Performance
[This section is a summary on quality of starting materials and supplier quality
performance]
5.1 New Sources
[List and report all raw materials (APIs, excipient and packaging materials) if
purchased from new source for the manufacturing of the product concerned and list
the status of the manufacturer (Table 4-1)]
Table 4-1
Material Name

Starting Material New Sources (Original manufacturer)

Material No. Manufacturer Name Manufacturer Status

Audit Status

5.2 Vendor Performance

[List the material name, material number, manufacturer Id, manufacturer status as
well as number of batches received, released, pending release and rejected during
the review period and list all deviation related to supplier to assess the performance
of vendor (Table 4-2)]
Table 4-2

Materia
l Name

Materia
l No.

Raw Material Received

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

6. Analytical Data and Trend Analysis

[List the Testing Monographs that have been applied (Table 5-1) and short conclusion
about data quality and trends]
Table 5-1
Testing Monographs
Material Name
Material No.

Document Code

Implementation Date

6.1 Analytical Data for Quality Parameters

[Provide a visual trending of the data using control chart and an overall statement as
to the degree of process control observed during the review period]

Product Quality Review

[Product Name Dosage Strength Dosage Form]
5.1.1 IPC-data
[Describe all critical in-process controls and finished product results. Explain deviations and
corrective action if applicable]
Table 5-2
IPC Results
Stage of the
Critical Parameter Acceptance Criteria Actual Results
process

Remark

5.1.2 Microbiological Data

[Comment on the overall performance of the microbiological data]
5.1.3 Analytical Method Trends For Release Batches
[List the test results and trends from QC tests for commercial release batches].
Table 5-3 Analytical Results
Critical Parameter Acceptance Criteria

Actual Results

Remark

5.1.4 Capability Process Evaluation

[Statistical analysis should be used to assess process stability and capability, including
provide control chart into the section.]
Table 5-4

Statistical Analysis based on Control Chart (IPC Results)

No. Test Parameter

Specification Limit Control Limit

(LSL&USL)
(LCL & UCL)

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

Statistical Analysis based on Control Chart (Analytical Results)

No. Test Parameter

Specification Limit Control Limit

(LSL & USL)
(LCL & UCL)

Result of
Control Chart

Remark

Product Quality Review

[Product Name Dosage Strength Dosage Form]

Table 5-7
No.

Process Capability Analysis (Analytical Results)

Test
Specification Limit Control Limit
Parameter (LSL & USL)
(LCL & UCL)

Cp
Cpk PPM Sigma Remark
value value total value

6.2 Results of the Product Stability Monitoring Program

[List all batches enrolled in the product stability program (Table 5-8). Summarize stability
data of all batches on stability. Statistical analysis must be used to evaluate the
adequacy of current internal release limits]
Table 5-8

Stabilities Studies

Material Name

Table 5-9
No.

Stability
Program

Table 5-10
No.

Material No. Batch No.

Study Type Time Point

Condition

Statistical Analysis based on Control Chart (Stability Results)

Test
Parameter

Specification
Control Limit Result of
Remark
Limit (LSL & USL) (LCL & UCL) Control Chart

Process Capability Analysis (Stability Results)

Stability
Test
Specification Limit Control Limit Cp
Cpk PPM Sigma
Remark
Program Parameter
( (LSL&USL)
(LCL&UCL) value value total value

6.3 Out of Specifications

[List the number of confirmed and un-confirmed OOS, including the root cause, corrective
and preventive actions (Table 5-11)]
Table 5-11

OOS Overview Table

Material Material Number of

Name
No.
OOS

Confirmed/
Uncorfimed

Reference to
Deviation No.

Root
Cause

CAPA

Product Quality Review

[Product Name Dosage Strength Dosage Form]
Table 5-12 OOS Status
No. Short Description

Status

7. Deviations
[List all critical and not critical deviations (Table 6-1)]
Table 6-1
No.

Deviation Overview Table

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

No. Short Description

Table 6-3

Root Cause

CAPA

Status of Deviation
Report

CAPA

Status of Deviation
Report

Non-Critical Deviations

No. Short Description

Root Cause

8. Changes to Process and Analytical Methods and Specifications

8.1 Process Changes
[Provide the summary in table format (Table 7-1) or state that no process changes have
been performed including material and manufacturing equipment]
Table 7-1
Change No.

Summary of Process Changes

Change Type

Short Description Date of Approval

Status Remark

Product Quality Review

[Product Name Dosage Strength Dosage Form]
8.2 Analytical Changes
[Provide the summary in table format (Table 7-2) or state that no analytical changes have
been performed]
Table 7-2
Change No.

Summary of Analytical Changes

Change Type

Short Description

Date of Approval

Status Remark

8.3 Specification Changes

[Provide the summary in table format (Table 7-3) or state that no specification changes have
been performed]
Table 7-3
Change No.

Summary of Specifications Changes

Change Type

Short Description

Date of Approval

Status Remark

8.4 Other Changes

[Provide the summary in table format (Table 7-4) or state that no other changes have been
performed]
Table 7-4
Change No.

Summary of Other Changes

Change Type

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)]

Product Quality Review

[Product Name Dosage Strength Dosage Form]

Table 8-1

Summary of Validation Activities

Process Step

Validation Document Reference

Status

10. Qualification Status of Relevant Equipment and Utilities

[Qualification status of relevant (major) equipment and utilities must be listed with changes
and deviations to the qualification status summarized (Table 9-1). The basis for the review
should be the current validation master plan]
Table 9-1

Summary of Qualified Equipment and Utilities

Equipment/ Utility

ID
Equipment

Qualification
Status

Change/
Deviation

Next
Qualification

11. Review of Quality (technical) agreements

[Quality Agreements with contractors or suppliers should be reviewed for up-to-dateness
(manufacturer contractor, test lab, supplier RM/PM), includes internal Sandoz Agreement
(Table 10-1)]
Table 10-1

Quality Agreement

Name of Contractor/
Reference
Sandoz Affiliates

Date of review Valid (Yes/ No)

Remark

12. Compliance with key regulation attributes

[Provide a statement on the status of compliance for the verifications of the key regulatory
attributes at a minimum. Appropiate actions are to be created for any identified compliance
gaps. The DRA is responsible to provide input on post marketing commitments.
Examples:
The review of the site documentation against registratioon dossiers was performed and
found to be compliant an satisfactory.
Or

Product Quality Review

[Product Name Dosage Strength Dosage Form]

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

Key Regulatory Attributes

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

Summary of Technical Complaints

Complaint Material Material

No.
Name
No.
12.2

Batch
No.

Short
Root
CAPA
Description Cause

Conclusion

Medical Complaints (Adverse Event)

[Provide a statement on medical complaints and the corresponding evaluation]

13. Return, Recalls, Market Withdrawals, Regulatory Alert
13.1

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.

Summary of Returned Product

Total Number of Returned

Reason

Product Quality Review

[Product Name Dosage Strength Dosage Form]
13.2

Recalls or Market Withdrawals

[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.

Total Number of Recalls Reason

14. Action Taken Following Previous PQR

[Summary and status of actions taken (including revalidation activities) following the
conclusions and recommendations from previous PQR. Any ongoing Compliance or
remediation activities are reviewed, and any overdue actions identified]
15. Annual Visual Examination of Retain Samples of Finished Products (For US APR
only)
[Perform a visual examination on retain sample and review the result on conformance to the
spesifications. Examination perform only for exported product to USA or because other
specific reason (currently not required)]
16. Conclusions and Recommendations
16.1 Adequancy of Previous Recommendations
[Provide a statement on the succes of corrective action in the last reporting period]
16.2 Conclusions and New Recommendations
[Evaluate all datas as a whole. Summarize and recommendate these data for actions,
including revalidation activities if needed]
Table 16-1

CAPA PIan

Action Descriptions

17. Annexes
18. Distribution

PIC

Due Date