Scaling PQR Across Multiple Sites: A Playbook for Global Pharma Teams You’ve got manufacturing facilities in India, packaging in Poland, and a QC lab in Canada. Each site runs its own version of the PQR—different templates, different KPIs, and different […]
Why We Need to Look at APQR Differently for Continuous Manufacturing The Annual Product Quality Review (APQR) is a familiar process for pharma companies. It’s where we pull together data from the past year to check how well our products […]
Batch Trends and Quality Signals: Using PQR as Your Pharma Crystal Ball Imagine if your PQR could predict future quality issues before they become costly deviations. That’s not just a dream—it’s what batch trend analysis in your PQR is designed […]
If you’ve ever sat across from an FDA inspector, you know the tension that builds when they start flipping through your Product Quality Review (PQR) documentation. One misplaced number, one vague investigation summary, one missing link between deviations and CAPAs—and […]
How PQS Ensures Compliance with FDA Regulations Pharmaceutical manufacturers operate in a highly regulated industry where compliance with FDA guidelines is essential for ensuring product quality and patient safety. The Pharmaceutical Quality System (PQS) serves as the backbone of compliance, […]
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