Equipment CQV Excellence
At Bench2Batch™ CMC Lifecycle Partners, we deliver science- and risk-driven Commissioning, Qualification, and Verification (CQV) services to ensure your manufacturing equipment is not only installed and tested — but truly fit for its intended process and product use. Our approach integrates CQV seamlessly with MSAT, process characterization, and process validation to enable faster readiness, stronger compliance, and sustained performance across the product lifecycle.
Our CQV Philosophy
Beyond checkbox IQ/OQ — toward fit-for-purpose systems
Traditional CQV often focuses on document completion. At Bench2Batch, we focus on process capability and GMP fitness, applying:
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ICH Q9 risk management
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ASTM E2500 principles
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FDA Process Validation lifecycle concepts
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Deep MSAT and scale-up experience
We commission, qualify, and verify equipment to demonstrate it can consistently deliver critical process parameters (CPPs) and meet product quality requirements — from development through commercial operations
End-to-End CQV Lifecycle Coverage
Design → Build → Test → Operate → Maintain
Our services include:
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URS & Design Qualification
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Process-linked GMP requirements
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CPP → equipment function mapping
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Vendor FAT / Site SAT
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Protocol development, review & execution
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Deviation management & acceptance
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Commissioning & Turnover
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Readiness planning and execution
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Pre-verification confirmation
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IQ / OQ / PQ (as applicable)
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Risk-based testing strategies
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Leveraging commissioning data per ASTM E2500
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Equipment & Systems Expertise
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Bioreactors & Seed Trains (single-use & stainless)
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Media / Buffer Prep & Hold Systems
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Disc-Stack Centrifuges
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Chromatography Skids & Columns (UNICORN-controlled)
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UF/DF & TFF Systems
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CIP / SIP Systems
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Process Tanks with Temperature Control
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Supporting utilities and automation interfaces
Our CQV approach is tightly coupled with process understanding, especially for high-risk unit operations.
Typical CQV Deliverables
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User Requirements Specifications (URS)
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System Impact & Risk Assessments (FMEA)
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FAT / SAT protocols & reports
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Commissioning plans & turnover packages
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IQ / OQ / PQ protocols & summary reports (as applicable)
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Verification reports & traceability matrices
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Deviation & change control support
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SOP inputs & maintenance strategy alignment
