GxP System Setup

GxP System Setup

Build a Strong, Inspection-Ready Compliance Framework Across GMP, GDP/GSDP, and GLP

AGON designs and implements end-to-end GxP systems that strengthen compliance, streamline operations, and ensure pharmaceutical facilities are fully audit and inspection ready. Our solutions cover the complete lifecycle of manufacturing, distribution, and laboratory activities — enabling organizations to meet global regulatory expectations, standardize processes, and operate with consistent quality and control from day one.

Quality Metrics (475 x 600 px) (2)
Quality Metrics (475 x 600 px)

What We Deliver

GMP – Manufacturing Compliance

Design and implementation of full end-to-end GMP quality systems
SOP development and documentation structure aligned with international standards
Quality Manual, Policies, and Master Index creation
Document control, CAPA, change control, and deviation management modules
Training and competency framework for GMP-aligned execution

GDP / GSDP – Distribution Quality

Design and qualification of warehouses and temperature-controlled storage areas
Development of SOPs, logs, distribution workflows, and compliance documentation
Risk assessments for transportation, storage, and product handling
Supply chain qualification and end-to-end distribution compliance reviews
Personnel training for GDP/GSDP-compliant storage and distribution practices

GLP – Laboratory Integrity

Facility layout and workflow design for controlled, efficient laboratory operations
Instrument qualification and method validation guidance
SOP and documentation structure for GLP-aligned operations
Data integrity assessments and traceability controls for analytical records
Laboratory staff competency and GLP awareness training

Why It Matters

Ensures full compliance with global GxP expectations from the first day of operations
Reduces regulatory and operational risks during inspections and audits
Establishes standardized, repeatable, and scalable processes across functional teams
Protects product integrity, data reliability, and patient safety across the value chain
Accelerates market readiness and strengthens long-term operational performance
Get a Custom GxP System Setup Plan

Contact

  • Building #10, Ground Floor, Business Park, Amman, Jordan
  • +962 (79) 1533337
  • m.abuzour@agonme.com

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

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