Annual Product Review (APR)

Annual Product Review (APR) / Product Quality Review (PQR)

This topic is part of the SG Systems Global regulatory glossary series.

Updated October 2025 • Quality Management • cGMP / ICH Q10

Annual Product Review (APR) and Product Quality Review (PQR) are management-level, data-driven evaluations of each marketed product to confirm a state of control, identify trends, and trigger improvements or remediation. In the U.S., APRs are required under 21 CFR 211.180(e). In the EU/EEA, PQRs arise from EU GMP Part I (Chapter 1) and are harmonised by ICH Q10 (Pharmaceutical Quality System). Bottom line: regulators expect you to systematically review what you made, what deviated, what changed, and what you’ll do about it.

“APRs/PQRs are not a binder exercise. They are the annual truth serum for product and process performance—and a forcing function for change.”

1) What It Is

An APR/PQR consolidates one year of product-specific GMP data: batches manufactured/released, in-process and finished results, OOS/OOT events, deviations, complaints/recalls/returns, changes, stability trends, supplier quality performance, and on-going process verification (OPV/CPV) signals. The review assesses whether the manufacturing process remains capable, whether control strategies still work, and whether CAPAs and changes were effective.

TL;DR: Compile one year of product data, analyse trends and capability, confirm validated state, document conclusions, and drive CAPAs/changes. If you can’t defend your APR/PQR, you can’t defend your product.

Scope. Drug products and APIs (U.S. Part 210/211; ICH Q7 for APIs), biologics (21 CFR 600–680), and—by best practice—advanced therapies. Many supplement and food manufacturers adopt an APR-like review under 21 CFR 111/117 to satisfy auditors and customers.

Typical APR/PQR contents.

  • Batch data: list of lots, yield/results summaries, critical quality attributes (CQAs) and in-process controls (IPCs) with trend charts; significant rejects/reworks.
  • Quality events: deviations, OOS/OOT, nonconformances; investigations, root causes, CAPAs, and effectiveness checks.
  • Changes: process/equipment/facility/material method changes; change control impact assessments; validation (PPQ/verification) outcomes.
  • Stability: study status, trends vs. specs; excursions; ongoing commitments.
  • Complaints/returns/recalls: patterns, severities, time-to-close, field actions.
  • Suppliers & materials: incoming test trends, supplier performance ratings, audit outcomes, second-source qualification status.
  • Process validation/CPV: capability (Cp, Cpk), alarms, control charts; continued process verification conclusions.
  • Regulatory commitments: filings/variations, post-approval changes, regulatory inspection outcomes.
  • Recommendations: targeted improvements, risk re-ranking, CAPA/Change Plan with owners and dates.

2) Practical Implementation & Cross-References

Frequency. At least annually and per marketing authorisation; align the period to meaningful data volume (e.g., calendar year) and lock the schedule in a procedure. For low-volume or seasonal products, include multi-year trend visuals.

Governance. Quality owns the process; manufacturing, QC/LIMS, engineering, supply chain, and pharmacovigilance/complaints contribute data. Final sign-off by QA with clear accountability for follow-up actions.

Data sources you’ll actually need:

  • eBR/MES lots, yields, holds, exceptions (MES)
  • LIMS results, OOS/OOT, method changes, stability (QMS + LIMS)
  • Deviation/NC/CAPA/Change Control records (QMS)
  • Supplier qualifications, COA trending, incoming QC (WMS + QMS)
  • Complaints/returns/recalls, field alerts (QMS)
  • Regulatory commitments and inspection outcomes (RA/QMS)
  • Master data/version history (recipes, specs, BOMs) (Recipe Management)
  • ERP interfaces for volumes, backorders, markets (V5 Connect API)

Cross-references. Tie APR/PQR to 21 CFR 210/211 (U.S.), EU GMP Part I Chap. 1 (EU), 21 CFR Part 11 (e-records/signatures), GAMP 5 (system validation), and EU GMP Annex 11 (computerised systems).

Reviewer’s quick checklist (what auditors ask to see):

  • Procedure defining scope, roles, data sources, statistical tools, and timelines.
  • List of batches with pass/fail and yield trends; capability indices for key CQAs/IPCs.
  • OOS/OOT/Deviation trend analysis with causes and CAPA effectiveness.
  • Change history mapped to risks and validation evidence (PPQ/verification records).
  • Stability trends with any shelf-life/labeling impact assessments.
  • Supplier performance metrics and re-qualification triggers.
  • Complaint/return/recall summaries with time-to-close and recurrence.
  • Written conclusions on state of control, and a signed CAPA/Change Plan with owners/dates.

3) Data, Metrics & Visuals that Matter

  • Process capability: Cp/Cpk for potency, assay, content uniformity, viscosity, pH, moisture, fill weight, etc.
  • Yield performance: actual vs. theoretical by stage; rework/scrap rates.
  • Exception rates: deviation frequency/1,000 lots; OOS by method; complaint rate per 10k packs.
  • Cycle times: release lead time, investigation aging, CAPA effectiveness lag.
  • Stability: trend lines vs. specs; excursion count; any negative slope on potency.
  • Supplier quality: COA failure rate; audit scores; on-time, in-spec delivery.
  • Validation drift: number of unplanned process adjustments; alarm frequencies.

4) How It Relates to V5

V5 by SG Systems Global consolidates APR/PQR evidence across production, lab, quality, and warehouse, enabling review-by-exception and traceable management decisions.

  • Source-truth data capture. eBR in MES captures weighings, sign-offs, holds; QMS logs deviations/CAPA/Change; WMS manages COA matching, status, and reconciliation.
  • LIMS integration. Bi-directional import of results, OOS flags, and stability data via V5 Connect API.
  • Trend packs & dashboards. Out-of-the-box KPIs (yields, exceptions, Cpk, complaint rate) plus CSV/XML exports for statistical deep-dives.
  • Audit trail & Part 11/Annex 11 alignment. Role-based access, e-signatures with meaning of signature, timestamped audit trails for every critical object.
  • Actionable output. Auto-generated APR/PQR summary with linked evidence, plus CAPA/Change Plans tracked inside QMS.

Example flow. End of year → V5 compiles batches, yields, and CQA trends → pulls LIMS OOS/OOT and stability → merges deviations/CAPA/Changes → generates product-level dashboards → QA leads review meeting → actions created in QMS with owners and due dates → effectiveness checks scheduled. Same dossier supports U.S. APRs and EU PQRs.

5) Implementation Playbook (Team-Ready)

  • Define the procedure: scope by MA number/SKU/market; inputs; stats; visuals; sign-offs; due dates.
  • Lock master data: versioned specs/recipes/BOMs in Recipe Management; map CQAs/IPCs to parameters.
  • Connect systems: enable feeds from ERP, LIMS, complaint system via V5 Connect.
  • Pre-compute trends monthly: don’t leave it to Q4; keep rolling dashboards to avoid firefighting.
  • Risk-rank findings: use severity/occurrence/detectability to focus the CAPA/Change Plan.
  • Close the loop: effectiveness checks and periodic review ensure improvements stick.

Related Reading

6) FAQ

Q1. APR vs PQR—what’s the difference?
The mechanics are similar. “APR” is the FDA terminology tied to Part 211.180(e); “PQR” is the EU term in Part I Chap. 1. Global companies harmonise one process/dossier to serve both.

Q2. Do we need APR/PQR for low-volume or legacy products?
Yes—regulators still expect an annual assessment. For sparse data, expand the window for trend plots and focus conclusions on risk and continued suitability.

Q3. What mistakes trigger findings?
Copy-paste binders; missing lots; no statistical analysis; CAPAs with vague owners/dates; untrended complaints; unlinked changes/validation evidence; late completion.

Q4. Can spreadsheets support APR/PQR?
Only with tight controls. Prefer validated systems. If you must use spreadsheets, apply Annex 11/Part 11 style controls (versioning, access, audits) and document verification steps.

Q5. Who signs the review?
Cross-functional reviewers contribute; QA (and where applicable, the Qualified Person) signs the final conclusions and improvement plan.

Related Glossary Links:
• FDA cGMP: Part 210 | Part 211 | 600–680
• EU/International: Annex 11 | ICH Q10 (referenced within site content)
• Data Integrity & Systems: Part 11 | Audit Trail | ALCOA+
• Mixed-Portfolio Controls: Part 111 | Part 117 | FSVP Part 1



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