What CPV Audits Cover
Continued process verification is the ongoing monitoring of a process to confirm that it remains in control. It is the third stage of process validation and it continues for the life of the product.
A GMP audit for CPV assesses whether monitoring is defined, whether data is collected and analyzed, whether trends are identified, and whether action is taken when needed. The scope includes monitoring plans, data collection, statistical analysis, trending, and action.
The Regulatory Context
FDA Process Validation Guidance
The FDA guidance describes a lifecycle approach with three stages, including continued process verification.
EU GMP Annex 15
Annex 15 covers qualification and validation, including ongoing verification.
ICH Q8, Q9, and Q10
ICH Q8 covers development, Q9 covers risk management, and Q10 covers the quality system.
PIC/S and WHO
PIC/S Guide PE 009 and WHO GMP guidelines cover validation and ongoing monitoring.
Also read: GMP Audit for Complaint Handling: Listening to the Market
What Audits Focus On
Monitoring Plans
Plans should define what is monitored and how. The audit should check that plans are documented.
Data Collection
Data should be collected accurately. The audit should check that data is reliable.
Statistical Analysis
Data should be analyzed. The audit should check that analysis is appropriate.
Trending
Trends should be identified. The audit should check that trends are evaluated and acted on.
Action
Action should be taken when needed. The audit should check that action is documented and effective.
Documentation
Records should be complete. The audit should check that documentation is contemporaneous.
Also read: GMP Audit for Training Systems: Building Competence
Common Findings in CPV Audits
Monitoring Plans That Are Incomplete
Data Collection Gaps
Analysis That Is Not Performed
Trending Gaps
Action Gaps
Documentation Gaps
Introducing GxP Cellators for CPV Audits
GxP Cellators provides GMP audits for continued process verification covering monitoring plans, data collection, statistical analysis, trending, action, 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.
Keep Processes in Control
Visit https://www.gxpcellators.com/gmp-auditing/ for service details. Email or use https://www.gxpcellators.com/contact/ to discuss your CPV audit.
Frequently Asked Questions About CPV Audits
What is CPV?
CPV is the ongoing monitoring of a process to confirm that it remains in control.
What should be monitored?
Critical process parameters and quality attributes.
How often should data be analyzed?
At defined intervals, typically with each batch or at defined points.
Can you help us prepare for an inspection of CPV?
Yes. We conduct readiness reviews and mock inspections.
How do I request a CPV audit?
Email or use https://www.gxpcellators.com/contact/. Service details are at https://www.gxpcellators.com/gmp-auditing/.
