How PQR Helps You Justify Process Validations and Revalidations

How PQR Helps You Justify Process Validations and Revalidations 

Ever wondered how to make your process validation plans more bulletproof during audits? 

Your Product Quality Review (PQR) might be the most underused—and most powerful—tool in your arsenal. 

Let’s explore how you can mine your PQR data to justify both initial process validations and revalidations, while aligning with regulatory expectations. 

PQR: The Bridge Between Routine Data and Validation Strategy 

 PQRs compile real-world manufacturing data over time. This includes trends in critical quality attributes (CQAs), deviations, out-of-spec results, and equipment performance. All of these can—and should—influence your validation lifecycle. 

For Initial Validations: 

 Use historical batch data to set justified acceptance criteria. 

 Highlight CQAs that show tight control across products and sites. 

For Revalidations: 

 Look for data drift, process variability, or equipment wear and tear flagged in the PQR. 

 Consider any significant changes in raw materials, equipment, or procedures that may have introduced new risk. 

When PQR Data Signals the Need for Revalidation 

 Regulators expect manufacturers to proactively detect when a process may be slipping out of control. Revalidation isn’t just scheduled—it’s triggered. 

Red Flags from Your PQR Might Include: 

 Increasing deviation trends 

 Shifting assay or dissolution results 

 CAPAs related to process performance 

 Higher-than-normal batch rejection rates 

Each of these can build your justification for a revalidation protocol. 

The Role of Trending Tools and Visual Analytics 

 It’s not enough to say “our yields are stable.” Show the story. SPC charts, box plots, and control maps help visualize process health over time. PQRs should include these visuals, making the case for—or against—revalidation. 

 Pro Tip: Integrate your QMS with analytics dashboards so trends automatically populate into your PQR. 

How This Supports Regulatory Expectations 

 The FDA and EMA emphasize risk-based validation strategies. They expect your process validation approach to evolve with operational data. 

When inspectors ask, “Why did you revalidate this process?” or “Why haven’t you?”—your PQR becomes your answer key. 

 Quote It: Include PQR-derived justifications directly in your revalidation protocol. 

From Compliance to Confidence 

 When PQRs guide your validation efforts, you move from reactive to proactive. You show regulators that your process is not just validated—it’s controlled and continuously monitored. 

That’s what makes the difference in inspections—and in patient safety. 

Final Thought: One Report, Multiple Wins 

 A well-leveraged PQR doesn’t just tick a compliance box. It informs your risk strategy, strengthens your validation program, and proves your quality commitment. 

Want to see how QEdge simplifies this connection between PQR and validation planning? Let’s start a conversation.