What APQR Audits Cover
The annual product quality review is a periodic review of product data to confirm that the process remains in control and that improvements are identified. It is a requirement in many jurisdictions and a valuable tool for continual improvement.
A GMP audit for APQR assesses whether the review is performed, whether it covers the required data, whether trends are identified, and whether actions are taken. The scope includes data sources, analysis, conclusions, and actions.
Also read: GMP Audit for Change Control: Managing Change Without Risk
The Regulatory Context
EU GMP Chapter 1
Chapter 1 of EudraLex Volume 4 requires a periodic product quality review.
FDA 21 CFR 211 and Product Review
The FDA requires that product quality be reviewed, and the annual product review is part of the expectation.
ICH Q10
ICH Q10 links product review to continual improvement.
PIC/S and WHO
PIC/S Guide PE 009 and WHO GMP guidelines cover product quality review.
What Audits Focus On
Performance
Reviews should be performed at defined intervals. The audit should check that reviews are completed.
Data Sources
Reviews should use the required data. The audit should check that data is complete.
Analysis
Reviews should analyze data. The audit should check that analysis is appropriate.
Conclusions
Reviews should reach conclusions. The audit should check that conclusions are supported.
Actions
Reviews should lead to action. The audit should check that actions are documented and effective.
Documentation
Records should be complete. The audit should check that documentation is available.
Common Findings in APQR Audits
Reviews That Are Not Performed
Data Sources That Are Incomplete
Analysis That Is Not Performed
Conclusions That Are Not Supported
Actions That Are Not Taken
Documentation Gaps
Also read: GMP Audit for Biologics and Biosimilars: Managing Complexity
Introducing GxP Cellators for APQR Audits
GxP Cellators provides GMP audits for annual product quality review covering performance, data sources, analysis, conclusions, actions, and documentation.
We work across FDA, EMA, Health Canada, MHRA, WHO, and PIC/S frameworks. Our auditors bring regulatory inspection and industry quality experience, and we deliver clear, prioritized reports with practical remediation guidance.
Learn From Your Data
Visit https://www.gxpcellators.com/gmp-auditing/ for service details. Email or use https://www.gxpcellators.com/contact/ to discuss your APQR audit.
Frequently Asked Questions About APQR Audits
What is an APQR?
An APQR is a periodic review of product data to confirm control and identify improvements.
What data should be included?
Batch data, deviations, complaints, OOS results, stability, changes, and CAPA.
How often should it be performed?
Typically annually, or at a defined interval based on the product.
Can you help us prepare for an inspection of APQR?
Yes. We conduct readiness reviews and mock inspections.
How do I request an APQR audit?
Email or use https://www.gxpcellators.com/contact/. Service details are at https://www.gxpcellators.com/gmp-auditing/.
