📘 Preparation of Annual Product Review (APR)

The Annual Product Review (APR) (also referred to as Product Quality Review – PQR in EU) is a regulatory requirement under 21 CFR 211.180(e) and ICH Q7/Q10. Its purpose is to ensure product quality, process consistency, and regulatory compliance throughout the lifecycle.

🔹 Steps in Preparing APR

1. Planning & Responsibility

   • Establish an APR schedule for each product.

   • Define responsibilities: QA usually coordinates, while QC, Production, Regulatory, and Supply Chain provide inputs.

2. Data Collection
   Gather data from the previous review period (usually 12 months):

   • Batch records: number of batches manufactured, released, rejected.

   • Deviations & CAPAs related to the product.

   • OOS / OOT results in QC testing.

   • Change controls implemented (formulation, process, equipment, supplier changes).

   • Stability data (ongoing and commitment studies).

   • Market complaints, returns, and recalls.

   • Supplier qualification & raw material issues.

   • Process validation & cleaning validation status.

   • Equipment maintenance and calibration records.

3. Trend Analysis

   • Perform statistical evaluation of batch yield, critical process parameters (CPPs), and critical quality attributes (CQAs).

   • Identify recurring deviations or quality signals.

   • Assess compliance with specifications and acceptance criteria.

4. Evaluation

   • Determine if the product remains in a state of control.

   • Evaluate need for re-validation or process improvements.

   • Review adequacy of corrective and preventive actions.

   • Assess effectiveness of change controls.

5. Recommendations & Action Plan

   • Summarize findings.

   • Propose CAPA, process optimization, or additional training if needed.

   • Document rationale for no further action if applicable.

6. Approval & Archiving

   • QA prepares the final APR report.

   • Get approvals from Quality Head and site management.

   • Ensure timely archival and readiness for inspection.

✅ Benefits of APR

• Ensures product and process consistency.

• Helps detect trends before they lead to failures.

• Demonstrates compliance during regulatory inspections.

• Supports continual improvement.

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