Facing a regulatory audit? Your Product Quality Review (PQR) might just be the most scrutinized document in the room. Whether it’s the FDA, MHRA, or WHO, inspectors expect more than a checklist — they expect a narrative that shows you […]
Product Quality Review (PQR)
Contract Manufacturing Organizations (CMOs) play a major role in the pharmaceutical supply chain. However, when it comes to Product Quality Review (PQR), there’s often confusion about responsibilities, documentation access, and compliance expectations. Here are the most frequently asked questions from […]
For pharmaceutical companies operating on a global scale, staying compliant is like walking a tightrope across multiple regulatory systems. Your Product Quality Review (PQR) might pass an FDA inspection, but does it hold up against EMA or WHO expectations? This […]
When we talk about the Product Quality Review (PQR) process in pharma, the focus is typically on Quality Assurance and Quality Control teams. But what if we told you that some of the most valuable insights are being missed simply […]
The Executive’s Guide to PQR: Turning Compliance Reviews Into Boardroom Metrics Let’s be honest: for many senior leaders in pharma, the Product Quality Review (PQR) is perceived as a checkbox—necessary, regulatory, and far removed from strategic conversations. But what if […]
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 […]
Your PQR Isn’t ‘Done’ Without These Five Post-Review Actions Too many teams breathe a sigh of relief once the Product Quality Review (PQR) is compiled, signed off, and archived. But let me ask you this: what happens next? If the […]
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