Product Quality Review

[Product Name Dosage Strength Dosage Form]

N PQR_XXX_YYYY

Period: DD/MM/YYYY - DD/MM/YYYY

Disiapkan Oleh :
Prepared By Tanggal
Date

Disetujui Oleh :
Approved By Tanggal
Date

Disetujui Oleh :
Approved By Tanggal
Date

Disetujui Oleh :
Approved By Tanggal
Date

Disetujui Oleh :
Approved By 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 Batches Manufactured

Material Material Batches Batches Batches Pending Batches
Name No. Manufactured Released 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 Material Deviation
Rework/ Reprocess
Name No. No. Reference Status Reference
Operation

[Describe the production process flow diagram]

 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 Starting Material New Sources (Original manufacturer)

Material Name 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 Raw Material Received

Number
Number Number
Manufacture Audit of Number
Materia Materia Manufacture Of of
r Statu batches of Bathes
l Name l No. r Name Bathes Pending
Status s Receive Rejected
Released Release
d

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 Remark
process

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)

Specification Limit Control Limit Result of

No. Test Parameter Remark
(LSL&USL) (LCL & UCL) Control Chart

Table 5-5 Process Capability Analysis (IPC Results)

No. Test Specification Control Limit Cp Cpk PPM Sigma Remark
Parameter Limit (LSL & USL) (LCL & UCL) value value total value

Table 5-6 Statistical Analysis based on Control Chart (Analytical Results)

Specification Limit Control Limit Result of

No. Test Parameter Remark
(LSL & USL) (LCL & UCL) Control Chart
 Product Quality Review
[Product Name Dosage Strength Dosage Form]

Table 5-7 Process Capability Analysis (Analytical Results)

Test Specification Limit Control Limit Cp Cpk PPM Sigma Remark

No.
Parameter (LSL & USL) (LCL & UCL) 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 Material No. Batch No. Study Type Time Point Condition

Table 5-9 Statistical Analysis based on Control Chart (Stability Results)

Stability Test Specification Control Limit Result of

No. Remark
Program Parameter Limit (LSL & USL) (LCL & UCL) Control Chart

Table 5-10 Process Capability Analysis (Stability Results)

Stability Test Specification Limit Control Limit Cp Cpk PPM Sigma

No. 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 Confirmed/ Reference to Root

CAPA
Name No. OOS Uncorfimed Deviation No. Cause
 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 Deviation Overview Table

Critically
Material Batch Local Number of Defect
No. Material No. (Critical/
Name No. 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

Status of Deviation
No. Short Description Root Cause CAPA
Report

Table 6-3 Non-Critical Deviations

Status of Deviation
No. Short Description Root Cause CAPA
Report

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 Summary of Process Changes

Change No. 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 Summary of Analytical Changes

Change No. 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 Summary of Specifications Changes

Change No. 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 Summary of Other Changes

Change No. 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

ID Qualification Change/ Next

Equipment/ Utility
Equipment Status Deviation 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 Date of review Valid (Yes/ No) Remark
Sandoz Affiliates

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 post-
marketing 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 Batch Short Root

CAPA Conclusion
No. Name No. No. Description Cause

12.2 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 Summary of Returned Product

Batch No. 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 PIC Due Date

17. Annexes

18. Distribution