the consistency of the process, detect trends, and identify any opportunities for product or process improvements to ensure continual GMP compliance and product quality.

2. Scope

This SOP applies to all commercial injectable products manufactured at the facility. It includes data collection, collation, analysis, interpretation, and documentation of the findings in the APQR report for each product and its respective strength and dosage form.

3. Responsibilities

• QA Executive: Collects and compiles data, drafts the APQR, and maintains records.
• Production Head: Provides data on manufacturing, deviations, and equipment performance.
• QC Manager: Supplies analytical, stability, and OOS/OOT results.
• Regulatory Affairs: Informs of any regulatory changes affecting the product.
• Head QA: Reviews and approves the final APQR reports and ensures timely completion.

4. Accountability

The Head of Quality Assurance is accountable for timely preparation, review, and approval of APQRs as per regulatory timelines and GMP standards.

5. Procedure

5.1 Planning and Schedule

1. QA shall prepare an annual schedule for APQR preparation for all marketed products at the beginning of each calendar year (Annexure-1).
2. APQRs must be completed within 90 days of the end of the review period (calendar year or fiscal year).

5.2 Data Collection

1. Collect and compile data related to:
   • Batch manufacturing records (Annexure-2)
   • Analytical data including assay, impurities, pH, endotoxin, sterility, and particulate matter
   • In-process controls and yield data
   • Deviations, change controls, OOS, OOT, CAPAs
   • Market complaints and product recalls
   • Stability study results
   • Environmental monitoring and utility data

5.3 Report Compilation

1. The APQR report (Annexure-3) shall be prepared in a standardized format including:
   • Product details, strengths, and manufacturing locations
   • Executive summary with highlights of trends or deviations
   • Graphical representation of key parameters and trends
   • Conclusions and recommendations for improvement

5.4 Review and Approval

1. The draft APQR shall be reviewed by department heads for respective inputs and signed off.
2. Final review and approval shall be done by Head QA.

5.5 Corrective and Preventive Actions

1. If any unfavorable trends or quality concerns are identified, appropriate CAPA shall be raised and tracked (Annexure-4).
2. CAPAs shall be reviewed in subsequent APQRs for effectiveness.

5.6 Documentation and Archival

1. Approved APQR reports shall be archived electronically and physically with proper indexing.
2. Retention period shall be as per company policy or at least 5 years.

6. Abbreviations

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

7. Documents

1. Annual APQR Schedule – Annexure-1
2. Batch Data Summary Sheet – Annexure-2
3. APQR Template – Annexure-3
4. CAPA Summary Sheet – Annexure-4

8. References

• ICH Q10: Pharmaceutical Quality System
• WHO Technical Report Series 986
• 21 CFR Part 211.180(e) – Annual Review Requirements

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	QA Executive	QA Manager	Head QA
Department	Quality Assurance	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Annual APQR Schedule

Product Name	Review Period	Due Date	Assigned QA
Injexol 500 mg	Jan–Dec 2024	31/03/2025	Rajesh Kumar

Annexure-2: Batch Data Summary

Batch No.	Yield (%)	Deviation	OOS
INX2401	97.2	None	No
INX2402	96.5	Yes	No

Annexure-3: APQR Template

Section	Details
Product Name	Injexol 500 mg
Batch Summary	12 batches reviewed, average yield: 96.8%
Stability Trends	All within specification
Deviations	1 minor deviation
Complaints	No market complaints

Annexure-4: CAPA Summary

Issue	CAPA	Status	Responsibility
Yield below target	Re-train operators on compounding	Completed	Production Manager

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
24/06/2025	2.0	Updated annexures and review scope	Periodic Review	QA Head