complaints, and validation status.

3. Responsibilities

• QA Executive: Coordinates data collection, compiles and reviews the APQR draft.
• Functional Departments (Production, QC, Warehouse, Regulatory Affairs): Provide required data and supporting documents.
• QA Manager: Reviews compiled report and recommends for approval.
• Site Head/Plant Manager: Provides final approval of APQR.

4. Accountability

The Head of Quality Assurance is accountable for ensuring the accuracy, completeness, and timely submission of APQRs to meet internal and regulatory requirements.

5. Procedure

5.1 APQR Calendar and Product List

1. QA shall prepare and maintain an Annual APQR Calendar (Annexure-1) listing all products requiring review.
2. The calendar must be approved by QA Head and shared with department heads.

5.2 Data Collection

1. QA shall collect the following data for the review period (typically Jan–Dec):
   • Batch manufacturing and release data
   • Yield trends
   • Deviation and non-conformance reports
   • Change controls
   • Market complaints and recalls
   • OOS/OOT results
   • Stability study status
   • Analytical method changes
   • Validation/revalidation data
   • Environmental monitoring data
2. Data to be submitted in soft copy and/or controlled formats by relevant departments using the Data Submission Template (Annexure-2).

5.3 Compilation of APQR

1. QA shall compile data into the APQR Compilation Template (Annexure-3) including:
   • Product overview
   • Manufacturing summary and yields
   • Quality metrics and trends
   • Stability performance
   • Regulatory commitments and deviations
   • CAPAs implemented
   • Recommendations for improvement
2. Graphical and tabular representations must be included where applicable.

5.4 Review and Approval Process

1. QA Manager shall review the draft APQR for:
   • Completeness
   • Consistency of data
   • Corrective actions suggested
2. Final report shall be approved by QA Head and Site Head.
3. All approval signatures must be dated, and the APQR must be version controlled.

5.5 Submission and Archival

1. Approved APQRs shall be:
   • Shared with Regulatory Affairs and retained for inspection readiness
   • Archived in both hard copy and electronic format
2. Retention period: Minimum 5 years or as per local regulations.

5.6 Trending and Improvements

1. Based on APQR findings, QA shall initiate recommendations which may include:
   • Process optimization
   • SOP revision
   • Further training
   • Revalidation
2. Action points to be documented and followed via CAPA system.

6. Abbreviations

• APQR: Annual Product Quality Review
• QA: Quality Assurance
• OOS: Out of Specification
• OOT: Out of Trend
• CAPA: Corrective and Preventive Action

7. Documents

1. APQR Calendar (Annexure-1)
2. Data Submission Template (Annexure-2)
3. APQR Compilation Template (Annexure-3)
4. CAPA Tracking Sheet (Annexure-4)

8. References

• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211.180(e) – APQR
• EU GMP Part I – Chapter 1 and 9

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: APQR Calendar

Product Name	API Code	Review Period	Due Date	Status
API-X	AXP001	Jan–Dec 2024	31/03/2025	Pending

Annexure-2: Data Submission Template

Department	Data Type	Format	Submitted On
QC	OOS Report Summary	Excel	01/03/2025

Annexure-3: APQR Compilation Template

Section	Data Summary	Remarks
Yield Trend	Average: 98.5%	Within control limits
Deviations	2 major, 3 minor	Investigated and closed

Annexure-4: CAPA Tracking Sheet

CAPA No.	Action	Owner	Due Date	Status
CAPA/2025/04	Update granulation SOP	Production	10/04/2025	Open

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial version	New document	QA Head
14/04/2025	2.0	Added CAPA tracking and annexures	Process enhancement	QA Head