Europe's Drug Shortage Solution
Services Included
We are not a CMO, we are a pharma cooperative built to enable the best mid-tier pharma companies pool resources, reduce costs and get exclusive EU market access. EUMA Pharma builds, owns and operates the cGMP compliant facility and hold MA license to distribute products.
We provide the validated facility and all the Quality Assurance, Quality Control, Manufacturing, Engineering, Calibration, Maintenance, Validation, Supply Chain, Cleaning, Environmental Monitoring, and Quality System services so that you can focus on what you do best, develop life-saving medicines and protect patients.
Each cooperative member owns their own individual suite for their manufacturing operations. We operate a shared office, utility, cleaning, quaility control, warehouse, packing model to ensure cost efficiency and regulatory compliance. We partner with qualified vendors for any support activities not performed in-house.
ISO Certified Cleanrooms
Dedicated Manufacturing Space
Each of our cooperative members get a dedicated manufacturing suite for their sole use. Our Cleanrooms are designed and built using the latest technology and standards. All cleanrooms are qualified to ISO-14644 standards.
Qualified HVAC and Critical Utilities
Validated
We risk assess each system to determine the appropriate level of qualification. We commission and qualify following FDA, EU, PIC/S requirements using industry best practices from ISPE, ASME, and the PDA.
GMP Compliant Quality System
Data Integrity
Reliable data is critical in GMP manufacturing. We use enterprise-grade cloud-based IT systems for Quality Management, Documentation, Training, Supply Chain, Calibration, Maintenance, and Validation operations.
Supply Chain Management
ERP and QP Release
We take care of all Quality, QP, Supply Chain and Warehousing operations on our enterprise-grade quality system. We perform vendor qualification and management and store all your temperature-sensitive materials in qualified Fridges, Freezers, or Liquid Nitrogen.
Cleaning and Environmental Monitoring
Validated Cleaning
We perform continuous Cleaning and Environmental Monitoring of the cleanrooms. We use validated detergents, biocides, and sporicides to ensure cleanliness. We ensure that all cleanrooms are maintained within viable and non-viable particle limits as defined in ISO 14644.
Quality Control and Release Testing
QC Testing
We perform all Environmental and Critical Utility Monitoring in-house to ensure compliance with regulated standards. We perform all QC release testing to support your operation. Please discuss your QC testing requirements with us.
Calibration and Maintenance
CMMS System
We manage and perform all Calibration and Maintenance activities to ensure ongoing compliance and reliability. All executed data is stored in our GxP compliant Calibration Maintenance Management System (CMMS). We can manage the calibration and maintenance of your process equipment also.
Ongoing Validation
Validation
We ensure ongoing compliance to regulatory standards by performing Periodic Reviews and Periodic Revalidation on all systems, including requalification of the Cleanrooms, process equipment, clean utilities, Bio Safety Cabinets (BSCs) Incubators, Fridges, Freezers, and Liquid Nitrogen freezers. We execute all validation activities.