Annual Product Quality Review (APQR) Preparation Checklist
Annual Product Quality Reviews drive continuous pharmaceutical quality improvement. This checklist ensures APQR data collection, analysis, and reporting meets FDA 21 CFR 211.180(e) and ICH Q10 requirements.
- Industry: Pharmaceutical & Life Sciences
- Frequency: Annual
- Estimated Time: 45-60 minutes
- Role: QA Manager / Quality Director
- Total Items: 31
- Compliance: FDA 21 CFR 211.180(e) - Annual Product Review Requirements, ICH Q10 Section 3.2.3 Annual Product Review, EU GMP Chapter 1.10 - Annual Product Quality Review, FDA Guidance for Industry - Quality Systems Approach to CGMP Regulations
Raw Material and Component Quality
Review material quality trends.
- Raw material and component rejection rates trended and within targets?
- Any supplier changes during review period documented and managed?
- Any new or revised material specifications issued during period?
- Critical starting material supply chain risks assessed?
- Material shelf life or retest date compliance reviewed?
Process and Batch Data
Review process performance data.
- All batches manufactured in period included in APQR?
- Batch yield trends reviewed and within historical limits?
- Critical Process Parameter (CPP) trending reviewed?
- Production deviation rate trended and compared to prior year?
- Process improvements implemented during period documented?
Quality Control Testing
Review QC testing data.
- All release test results trended for the period?
- OOS rate trended and compared to prior year?
- Any test method changes during period documented?
- Stability data reviewed with no adverse trending?
- Shelf life confirmed by available stability data?
Quality Events and Complaints
Review complaints and quality events.
- All product complaints during period reviewed and trended?
- Any recall or field alert events reviewed?
- Complaint rate compared to prior year with no adverse trend?
- Returned goods and destructions reviewed?
- Adverse drug reaction reports reviewed?
Regulatory Changes and Commitments
Review regulatory status.
- All regulatory approved changes during period documented?
- Post-approval commitments met?
- Contract manufacturing or testing organization performance reviewed?
- Any regulatory agency actions or inspections related to product reviewed?
- Product marketing authorization current in all markets?
APQR Report and Actions
Complete APQR report.
- Statistical trending (SPC or control charts) completed for CQAs?
- APQR conclusions clearly stating if the product remains suitable for its intended use?
- CAPAs initiated for all adverse trends identified?
- APQR reviewed and approved by Quality Director?
- Actions from prior year APQR reviewed and closed?
- Completed APQR filed in document management system?
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Why Use This Annual Product Quality Review (APQR) Preparation Checklist?
This annual product quality review (apqr) preparation checklist helps pharmaceutical & life sciences teams maintain compliance and operational excellence. Designed for qa manager / quality director professionals, this checklist covers 31 critical inspection points across 6 sections. Recommended frequency: annual.
Ensures compliance with FDA 21 CFR 211.180(e) - Annual Product Review Requirements, ICH Q10 Section 3.2.3 Annual Product Review, EU GMP Chapter 1.10 - Annual Product Quality Review, FDA Guidance for Industry - Quality Systems Approach to CGMP Regulations. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Annual Product Quality Review (APQR) Preparation Checklist cover?
This checklist covers 31 inspection items across 6 sections: Raw Material and Component Quality, Process and Batch Data, Quality Control Testing, Quality Events and Complaints, Regulatory Changes and Commitments, APQR Report and Actions. It is designed for pharmaceutical & life sciences operations and compliance.
How often should this checklist be completed?
This checklist should be completed annual. Each completion takes approximately 45-60 minutes.
Who should use this Annual Product Quality Review (APQR) Preparation Checklist?
This checklist is designed for QA Manager / Quality Director professionals in the pharmaceutical & life sciences industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.