📊 Annual Product Quality Review (APQR / APR / PQR) in Quality Improvements

🔎 What is APQR / APR / PQR?

• A systematic, documented review of all licensed products conducted annually (or periodically) as per ICH Q10, EU GMP, and FDA requirements.

• Objective: To verify the consistency of the manufacturing process, detect trends, and identify opportunities for quality improvement.

📝 Key Elements of APQR

1. Review of Batches

   • Summary of manufactured batches and yield trends.

   • Deviations, failures, and non-conformities.

   • Rejections, reprocessing, and recalls.

2. Critical Quality Attributes (CQA) & In-Process Controls

   • OOS, OOT, and OOE trends.

   • In-process testing compliance.

   • Process capability evaluation.

3. Starting Materials & Packaging Components

   • Supplier performance review.

   • Deviations or complaints related to materials.

   • Qualification and requalification status of suppliers.

4. Stability Studies

   • Ongoing stability data evaluation.

   • Identification of degradation trends.

   • Review of storage and distribution conditions.

5. Changes & CAPA Effectiveness

   • Summary of implemented change controls.

   • Effectiveness of corrective and preventive actions.

   • Recurrent deviations and CAPA failures.

6. Complaints & Product Quality Issues

   • Complaint classification and trend analysis.

   • Adverse drug reaction reports (if applicable).

   • Product recalls or regulatory notifications.

7. Validation & Qualification

   • Process validation and revalidation needs.

   • Cleaning validation and analytical method validation reviews.

   • Equipment qualification status.

✅ Role of APQR in Quality Improvements

1. Trend Identification

   • Detects recurring deviations, OOS, or process variability early.

   • Helps identify weak points in manufacturing and testing.

2. Process & Product Consistency

   • Verifies that processes remain in a state of control.

   • Identifies if re-validation or process optimization is required.

3. Supplier & Material Control

   • Improves supply chain reliability by monitoring vendor performance.

   • Supports requalification or delisting of poor-quality suppliers.

4. Regulatory Compliance

   • Demonstrates continued suitability of the manufacturing process.

   • Satisfies FDA (21 CFR 211.180(e)), EU GMP (Part I, Ch. 1.10), and WHO requirements.

5. Quality Culture & Continuous Improvement

   • Engages cross-functional teams (QA, QC, Production, Regulatory).

   • Promotes data-driven decision-making.

   • Enhances patient safety and product quality.

📌 Example – Improvements from APQR Findings

• Issue: Multiple deviations in blending uniformity.

• APQR Review: Highlighted a recurring issue with equipment RPM variation.

• Improvement: Equipment recalibration + revised SOP → Reduced blend variability → More consistent batches.

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