Pharma Quality Experts

  🚀 GMP Essentials Series – Post #2 of #8: DQ – Verifying the Blueprint In our last post, we explored the URS ✅—the blueprint that defines what a system must do. Now, before any steel is cut or code is written, we enter the critical phase of Design Qualification (DQ). 🔍 Why is DQ Essential? Design Qualification is the formal, documented assurance that the proposed design—from vendor specs to engineering drawings—can fully meet every GMP-critical requirement outlined in your URS. It’s the gatekeeper that ensures non-compliant systems never reach your facility. 🛡️ DQ: Your First Line of Defense While some view DQ as a routine review, a robust DQ is a proactive risk mitigation tool. It’s the most cost-effective stage of validation—catching issues here costs a few document edits; catching them in OQ can mean months of delay and thousands in redesign. 💡 Core Objectives of DQ Traceability Bridge: DQ links URS requirements to the vendor’s Functional and Technical Specifications, creat...