In the evolving landscape of pharmaceutical manufacturing, **ongoing process verification** (also known as **continued process verification**) remains a cornerstone of compliance. Introduced as part of the **process validation life cycle**, this stage ensures processes stay robust amid real-world variables. Drawing from insights shared by Dr. Franz Schönfeld, a seasoned European GMP inspector, during an ECA Academy course, this post explores what inspectors expect—and how your team can meet those standards. If you're navigating GMP regulations, these perspectives could refine your validation strategy.
## Understanding the Process Validation Life Cycle: The PDAC Framework
At its core, **process validation** follows a structured life cycle, often visualized as the PDAC cycle (Plan-Do-Check-Act). Using an active ingredient synthesis as a practical example, Dr. Schönfeld breaks it down:
- **Plan**: Identify and mitigate potential contamination risks through thorough risk assessments.
- **Do**: Execute validation within proven acceptable ranges, whether via traditional, hybrid, or continuous approaches.
- **Check**: Analyze validation run results against the plan, scrutinizing deviations for root causes.
- **Act**: Approve the process or implement enhancements, such as intensified sampling.
This cyclical model isn't a one-off; it's designed for perpetual improvement, making **ongoing process verification** indispensable for long-term control.
## Detecting Anomalies in the Commercial Phase: Key Triggers
One of the biggest challenges? Spotting anomalies post-launch, when production scales up. Dr. Schönfeld stresses that **continued process verification** is your frontline defense. Watch for these common triggers:
- Shifts in personnel, including leadership changes that could alter oversight.
- Equipment maintenance, repairs, or upgrades that subtly impact performance.
- Manufacturing deviations, no matter how minor.
- Emerging trends in analytical testing results.
- Rising customer complaints signaling quality drifts.
- Evolving regulatory requirements that demand process tweaks.
By leveraging extensive commercial data, **ongoing process verification** not only flags issues early but also drives data-backed refinements—transforming potential pitfalls into opportunities for optimization.
## Moving Beyond Routine Revalidation: A Smarter Approach
Gone are the days of periodic revalidations, especially in non-sterile manufacturing. **Ongoing process verification** steps in as a dynamic alternative, guided by an approved plan that outlines:
- The processes under review.
- Verification scope and frequency, tailored to your process maturity and incremental changes.
- Integration with broader quality systems.
This shift emphasizes proactive monitoring over reactive checks, aligning with EU GMP Annex 15 guidelines.
## Harnessing Statistics and Product Quality Reviews (PQR)
Statistics aren't optional—they're expected. Dr. Schönfeld highlights their role in **product quality reviews (PQR)**, where trend analysis is already commonplace. However, PQR serves products, not processes, and arrives too late in the cycle to substitute for dedicated verification.
Pro tip: Embed statistical tools in your **validation master plan (VMP)** to:
- Mandate change control evaluations for process stability.
- Set thresholds for cumulative changes that prompt deeper reviews.
- Adopt rolling reviews to catch trends in real time.
The result? A **continued process verification report** that clearly states if your process is controlled—and flags any need for extra monitoring or sampling.
## EU vs. US: Harmonized Yet Distinct
Comparing notes with the US FDA's Process Validation Guidance, Dr. Schönfeld notes semantic differences but a unified life cycle philosophy. Both regions prioritize stage 3 (continued verification) for sustained control, ensuring global harmonization without compromising local nuances.
## Common GMP Pitfalls: Lessons from Inspections
From his inspection tenure, Dr. Schönfeld flags recurring deficiencies in **process validation**, including gaps in anomaly detection and inadequate statistical rigor. While specifics vary, the takeaway is clear: Robust documentation and forward-thinking plans are non-negotiable to avoid citations.
## Final Thoughts: Elevate Your GMP Compliance Today
**Ongoing process verification** isn't just a regulatory checkbox—it's a strategic imperative for pharmaceutical excellence. As Dr. Schönfeld's expertise reveals, embracing this stage with data-driven vigilance can safeguard quality, streamline operations, and impress inspectors.
Ready to audit your processes? Review your VMP against these insights and consider ECA resources for deeper dives. Share your experiences with **continued process verification** in the comments—how has it shaped your GMP strategy?
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