Annexure II

GUIDELINE & SOP

Title : Annual Product Quality Review Report (APQR) Format

PRODUCT QUALITY REVIEW

FOR

(PRODUCT NAME)
Label claim: …………………………………..

APQR No.:

Period :

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 Annexure II
GUIDELINE & SOP
Title : Annual Product Quality Review Report (APQR) Format
TABLE OF CONTENTS
S. No. Title Page No.
1. Report Approval Sheet

2. Objective
3. Scope
4. Responsibility
5. Product Information
6. Review of supply chain integrity of API / Primary packing material.
7. Review of Starting Material
7.1. Source of packing Materials and its Specification Number
8. Review of Packaging Material
8.1 Source of packing Materials and its Specification Number are given below:
9. Review of Raw Material Rejections, Batch rejections and their investigations
10. Review of Packing Material Rejections, rejections and their investigations:
11. Review of critical manufacturing process parameters
12. Review of critical In process controls:
13. Review of Finished Products:
14. Review of all batches that failed to meet established specification
15. Review of OOS/OOT Quality impacting Incident
16. Review of Significant Deviations or Non Conformance
Review of changes product related in process specification or Analytical
17.
Methods
18. Review of Stability Monitoring program
Review of Microbiological and chemical testing of purified water & Review of
19.
Environmental monitoring data

20. Review of Validation batches data

21. Review of Quality Related Complaint / Recall / Any Investigation Conducted

21.1 Market Complaints

21.2 Batch Recalls

21.3 Returned/Salvaged Goods

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 Annexure II
GUIDELINE & SOP
Title : Annual Product Quality Review Report (APQR) Format

S. No. Title Page No.

22. Review of adequacy of any other previous product, process and equipment
23. corrective
Review of actions
Marketing Authorization Variation
24. Review of New Marketing Authorization variations
25. Review of Qualification Status of relevant Equipments / Utility
26. Review of Technical Agreements
27. Control Sample
28. Review of Corrective action and preventive action
29. Review of regulatory updates
30. Review of Commitments described in previous PQR
31. Summary
32. Conclusion
33. Recommendations
34. Abbreviations

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 Annexure II
GUIDELINE & SOP
Title : Annual Product Quality Review Report (APQR) Format
1.0 REPORT APPROVAL SHEET:

Prepared By:
Functional Area Name Signature Date

Quality Assurance

Reviewed By:
Functional Area Name Signature Date
Production

Quality Control

Engineering

Quality Assurance

Approved By:
Functional Area Name Signature Date

Head QA

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 Annexure II
GUIDELINE & SOP
Title : Annual Product Quality Review Report (APQR) Format
2.0 Objective:
The objective of product quality review is to review the critical in process and quality parameters and
to ensure that the product formula and manufacturing process is capable of producing the finished
goods in compliance to its predetermined quality attributes and specifications.
3.0 Scope:
This PQR is applicable for (Product Name) manufactured at ……………….
4.0 Responsibility:
Responsibility of the position or their designee:
4.1 Officer QA person:
4.1.1 To prepare PQR
4.1.2 To collect and compile data for continuous monitoring
4.2 Head-QA
4.2.1 To approve the PQR report
4.2.2 To suggest CAPA/recommendation in PQR
4.2.3 To ensure continuous monitoring data
4.2.4 To ensures the PQR is performed in a timely manner and is accurate
4.3 Head –Production:
4.3.1 To organize production related data for compilation
4.3.2 To review PQR for production related data and information
4.4 Head-Quality Control:
4.4.1 To provide QC related data for compilation in PQR
4.4.2 To review PQR for QC related data and information
4.5 Head-Engineering:
4.5.1 To review PQR
4.5.2 To address findings related to machine break down and equipment Functions in timely and effective
manner
5.0 Product Information.
5.1 Name of Product : …………..
5.2 Generic Name : -------
5.3 Shelf life : -- Months
5.4 Product code : -------
5.5 MFR No : -------
5.6 FPS No. :

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 Annexure II
GUIDELINE & SOP
Title : Annual Product Quality Review Report (APQR) Format
5.7 FTP No. :
5.8 Total batch : -- Batches
………..batches of ………. (Product Name) were manufactured during the period of
………………………………
Sr.No. Batch No. Mfg date Exp date Batch Size
1.

6.0 Review of supply chain integrity of API / Primary Packing material:

Name of the Name & address of Name & address Review Points
material / Approved of Authorized
Component manufacturer Supplier / Broker Change in Route Change in transit
or mode of condition
transport

7.0 Review of Starting Material:

All the starting materials used in the production of these batches are sourced from the approved
Vendors. The Active raw material found to comply as per current specifications.
7.1 Source of Raw materials and its specification number are given below:
Active used Item Specification *LOD /
Manufacturer AR. No Assay
code No. Water

* Write whichever is applicable

Trending of Assay as applicable for API

Excipients used Item code Specification No. Manufacturer

8.0 Review of Packaging Material:

All the packaging Materials for …………….. (Product Name) are procured from approved vendor and
found to comply as per specifications.
8.1 Source of packing Materials and its Specification Number are given below:
PM Used Item code Manufacturer AR. No Specification
Number

9.0 Review of Raw Material Rejections, Batch rejections and their investigations:
All the raw material used in (Product Name) Tablets manufactured from ……………….. Reviewed and

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 Annexure II
GUIDELINE & SOP
Title : Annual Product Quality Review Report (APQR) Format
no rejection has been found are as follows:

Sr. No RM rejection No. Product details AR No Reason

Inference:
10.0 Review of Packing Material Rejections, rejections and their investigations:
All the packing material used in (Product Name) Tablets manufactured from ………………..
reviewed and no rejection has been found are as follows:
Sr. No PM rejection No. Product details AR No. Reason

11.0 Review of critical manufacturing process parameters:

The granulation parameter was reviewed for ………. (Product Name) from ………………… and
found comply as per specification.
Stage Standard Limit Observation Remarks

Inference:

12.0 Review of critical In process controls:

The In process control parameter were reviewed for ………. (Product Name) from …………………
and found comply as per specification.
B. No. Critical In-process parameters as per BMR
Limits

Inference:

13.0 Review of Finished Products:

The Finished Products were analyzed and released as per specifications. All the tests were
reviewed and found comply as per specification.
Critical Parameters as per Finished Product
B. No. Assay % Yield
Specification
Limits

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 Annexure II
GUIDELINE & SOP
Title : Annual Product Quality Review Report (APQR) Format

Average
% SD
% RSD
Inference:
Trending of CQA with UCL and LCL
Calculation of Cpk as applicable

14.0 Review of all batches that failed to meet established specification

15.0 Review of OOS/OOT/Quality impacting incidence
16.0 Review of significant Deviations or Non Conformance
17.0 Review of changes product related, In process specifications or Analytical Methods
18.0 Review of Stability Monitoring Program
19.0 Review of Microbiological and chemical testing of purified water & Review of environmental
monitoring data
20.0 Review of Validation batches data
21.0 Review of Quality Related Complaint / Recall / Any Investigation Conducted
21.1 Market Complaints
21.2 Batch Recalls
21.3 Returned/Salvaged Goods
22.0 Review of adequacy of any other previous Product process and equipment corrective actions
23.0 Review of Marketing Authorization Variation
24.0 Review of the new Marketing Authorization Variation
25.0 Review of qualification status of relevant Equipment / Utility
26.0 Review of Technical Agreements
27.0 Control Sample
28.0 Review of Corrective action and preventive action
29.0 Review of regulatory updates
30.0 Review of commitments described in previous PQR
31.0 Summary:
Sr. No. Parameter Observation Inference
1.

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 Annexure II
GUIDELINE & SOP
Title : Annual Product Quality Review Report (APQR) Format
32.0 Conclusion
33.0 Recommendations
34.0 Abbreviations

Acronyms Abbreviations

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