Standard Operating Procedure for Annual Product Quality Review for Tablets

Department	Tablet
SOP No.	SOP/TAB/195/2025
Supersedes	SOP/TAB/195/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To define the process for conducting the Annual Product Quality Review (APQR) for tablet products to ensure ongoing product quality, identify areas for improvement, and ensure compliance with regulatory requirements.

2. Scope

This SOP applies to all tablet products manufactured within the facility. It describes the procedure for conducting an APQR to assess the quality of products over the previous year, ensure compliance with quality standards, and determine if any corrective actions are necessary.

3. Responsibilities

• Quality Assurance (QA): Responsible for leading the APQR process, reviewing product quality data, and preparing the APQR report.
• Production Team: Responsible for providing data related to production processes, batch records, and any deviations or incidents that may have impacted product quality.
• Regulatory Affairs: Responsible for ensuring that the APQR complies with applicable regulatory guidelines and addressing any regulatory concerns identified during the review process.
• Quality Control (QC): Responsible for providing analytical data and testing results for finished products, including stability data, potency, and other relevant parameters.

4. Accountability

The QA Manager is accountable for the overall APQR process, ensuring that the review is conducted on time, accurately, and in compliance with regulatory requirements. The Department Heads are responsible for providing relevant data and reports for the review process.

5. Procedure

5.1 Preparation for APQR

1. Identify the product batches to be included in the review period, typically covering the last 12 months of production.
2. Gather relevant data for the APQR, including batch records, deviations, non-conformances, complaints, and stability data for each product batch.
3. Ensure that all necessary departments (e.g., Production, QC, Regulatory Affairs) are involved in gathering data and providing their inputs for the review process.
4. Verify that all required reports and records are available, including any corrective actions taken during the review period (Annexure-1).

5.2 Review Process

1. Review the product batch records for each batch included in the review period, ensuring that all required steps were followed according to the relevant SOPs.
2. Assess the stability data for each product, including the results from stability studies and any changes in the product’s shelf life or storage conditions.
3. Evaluate any deviations, non-conformances, or complaints associated with each batch, ensuring that corrective actions have been taken and that these actions were effective in resolving the issues.
4. Analyze product performance data from QC testing, such as dissolution, content uniformity, and other critical quality attributes, ensuring that all products met the acceptance criteria (Annexure-2).
5. Review any changes made during the review period, including formulation changes, equipment upgrades, or changes in raw materials, and assess their impact on product quality.
6. Ensure that all compliance requirements are met, including GMP guidelines and any applicable regulatory requirements.

5.3 APQR Report

1. Prepare the APQR report summarizing the findings of the review, including any product quality trends, deviations, corrective actions, and improvements identified during the review period.
2. Include an assessment of whether the product meets the required regulatory standards and whether it is safe for continued use or distribution.
3. Provide recommendations for any necessary changes or improvements, such as modifications to processes, additional training for personnel, or updates to SOPs.
4. The APQR report should be reviewed and approved by the QA Manager and other relevant personnel (Annexure-3).

5.4 Corrective and Preventive Actions (CAPA)

1. If the APQR identifies areas where product quality or compliance can be improved, initiate corrective and preventive actions (CAPA) to address these issues.
2. Document all CAPA actions and ensure that they are implemented according to the established timelines.
3. Track the effectiveness of CAPA actions and ensure that they resolve any identified issues (Annexure-4).

5.5 Final Review and Approval

1. Once the APQR report is completed, it should be reviewed by the QA Manager and approved by the Regulatory Affairs Manager to ensure compliance with regulatory requirements.
2. Ensure that the APQR report is signed, dated, and archived for future reference and regulatory inspection.
3. Ensure that any corrective actions and preventive measures identified during the review are tracked and completed according to the CAPA plan.

5.6 Record Keeping

1. Maintain all documentation related to the APQR, including batch records, test results, deviation reports, CAPA records, and the final APQR report.
2. Ensure that all records are maintained for a minimum of five years or as required by regulatory guidelines (Annexure-5).

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• GMP: Good Manufacturing Practice
• CAPA: Corrective and Preventive Action
• FDA: Food and Drug Administration

7. Documents

1. APQR Report (Annexure-1)
2. Product Quality Data Summary (Annexure-2)
3. APQR Review Checklist (Annexure-3)
4. CAPA Action Plan (Annexure-4)
5. APQR Documentation Log (Annexure-5)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• ISO 9001 – Quality Management Systems
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

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 Report

Batch Number	Product Name	Test Results	Quality Trend	Recommendations
Batch-12345	Tablet A	Pass	Stable	No change required

Annexure-2: Product Quality Data Summary

Test Name	Specification	Test Results	Deviation
Dissolution	100%	99%	Pass

Annexure-3: APQR Review Checklist

Item	Reviewed By	Comments	Status
Batch Record Review	John Doe	No issues found	Complete

Annexure-4: CAPA Action Plan

Action ID	Action Description	Responsible Person	Completion Date
CAPA-001	Review stability testing methods	Jane Smith	01/05/2026

Annexure-5: APQR Documentation Log

Document	Version	Approval Date	Approved By
APQR Report	1.0	01/03/2026	QA Head

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated review process and timelines	Improved review procedures	QA Head