Continued Process Verification (CPV): A Pillar of Process Control and Compliance
By Silvia Cano, Equipment Qualification Area Technical Manager at Rephine
For many years, process validation in the pharmaceutical industry was synonymous with the documentation of three consecutive successful batches. While this approach provided some assurance of process consistency, it lacked the robustness needed to demonstrate long-term control. The shift towards Continued Process Verification (CPV) marks a significant evolution—one that aligns with both regulatory expectations and good manufacturing practice (GMP).
Today, CPV requires manufacturers to move beyond one-time validation and embrace continuous oversight, identifying trends and sources of variability to maintain a validated state and proactively improve processes.
CPV: Defined by Regulation
The principles of CPV are formalised in both US and European regulations:
FDA Guidance for Industry (2011):
“The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality products.”EU GMP Annex 15 (2015):
“The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.”
These regulatory frameworks reinforce the requirement for a lifecycle approach to process validation—with CPV as a key element of ongoing assurance.
Key Elements for Effective CPV Implementation
Establishing a robust CPV programme relies on the following foundational pillars:
Process Knowledge: Understanding the underlying process mechanisms is essential for interpreting results and detecting anomalies.
Qualified Equipment and Systems: All equipment and support services must be in a validated state to ensure data reliability.
Ongoing Data Acquisition: Parameters must be continuously or periodically monitored, recorded, and reviewed.
Statistical Evaluation: Competent use of statistical tools is critical for analysing process behaviour and drawing valid conclusions.
The Value of CPV
A well-executed CPV programme provides several tangible benefits:
Continuous evaluation of process stability and capability
Early detection of unexpected variability or drift
Identification of opportunities for process optimisation
Reduced likelihood of critical deviations and OOS results
Strengthened preparedness for regulatory inspections
Rephine’s Approach to CPV
At Rephine, we bring over two decades of experience in supporting pharmaceutical manufacturers across the globe with process validation. Our consultants combine deep regulatory insight with hands-on industry expertise to design and implement CPV programmes that are both compliant and pragmatic.
We help clients:
Define Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs)
Establish control limits and calculate capability indices (e.g., Cp, Cpk)
Implement data collection mechanisms
Apply appropriate statistical methods for data evaluation
Compile and maintain regulator-ready CPV reports
CPV in Practice: A Rephine Case Study
One of our recent projects involved supporting a pharmaceutical manufacturer that lacked internal resources to develop and execute a CPV strategy for a critical process. Rephine designed a site-wide CPV policy, supported statistical analysis, and prepared a comprehensive report based on historical data and ongoing production performance.
✅ The outcome:
- A tailored, scalable CPV model
- Improved process visibility
- Reduced non-conformity risk
- A structured, data-driven framework for future implementation
📄 Read the full case study to learn how Rephine delivered measurable improvements in process oversight and compliance.
Silvia Cano
Senior Consultant &
Equipment Qualification Area Manager
Final Thoughts
Continued Process Verification is no longer just a best practice—it’s a regulatory expectation. By adopting CPV, manufacturers can establish tighter control over their processes, reduce variability, and maintain a state of validation throughout the product lifecycle.
Rephine’s team of validation experts are ready to support you in designing and executing a CPV strategy that is tailored to your needs and aligned with GMP standards.