Process Validation

Process Validation

Validate Once. Manufacture with Confidence.

A validated process is your strongest proof of control and consistency. Agon’s Process Validation services help pharma manufacturers design, execute, and document validations that stand up to scrutiny—from regulators and internal stakeholders alike. Whether you’re launching a new product or revalidating an existing line, our lifecycle-based approach ensures your processes are robust, reproducible, and regulatory-ready.

What We Deliver

Stage-Wise Validation Lifecycle

Aligned with FDA’s 3-stage lifecycle: Process Design, Process Qualification (PPQ), and Continued Process Verification (CPV)
Protocol development, sampling plan, and critical process parameter (CPP) identification
End-to-end documentation for validation master plan (VMP), protocols, and reports

Execution & Analysis

On-ground support during validation batches (IQ/OQ/PQ, PPQ)
Statistical analysis and capability studies
Investigation support for failures, excursions, and process drifts

Continued Process Verification (CPV)

Control charts, control limits, and trend analysis dashboards
Annual review strategies and change control alignment
Integration with QMS and digital monitoring tools

Why It Matters

Validates that your process delivers consistent quality over time
Required for regulatory approval and product launch
Reduces batch failures and investigation costs
Demonstrates state of control to auditors and investors
Supports tech transfer, scale-up, and lifecycle extension

Categories

We understand the importance of approaching each work integrally and believe in the power of simple.

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