Europe's Drug Shortage Solution
EUMA Pharma
EUMA Pharma is Irelands only pharma cooperative ensuring continuity of supply of critical drugs, while giving EU manufacturing access to qualified global pharma companies.
EUMA Pharma operates licensed, cost-effective cGMP manufacturing in the EU for global companies supplying essential medicines but lacking an EU presence. We enable rapid EU access, strong compliance and reliable supply.
We operate under strict cGMP and MIA conditions and provide QP release, storage, distribution and full quality oversight to support safe, efficient market entry.
Feel free to contact us to get more information and join our waiting list.
Services Included
EUMA Pharma provides EU-focused pharmaceutical manufacturing infrastructure and services to ensure reliable production of essential medicines. We deliver GMP-compliant facilities, cleanrooms, utilities, calibration, maintenance, validation, cleaning, supply chain, environmental monitoring and full quality-system support so member companies can focus on producing safe, effective medicines for patients.
We use a cooperative manufacturing model designed for resilience, shared capacity and regulatory compliance. Cooperative members own their individual manufacturing suite and have shared access to administration, warehousing, quality assurance, engineering, quality control, supply chain to provide cost effective, efficient and compliant drug manufacturing and QP release.
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 Systems
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 System 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 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.
Validation and Compliance of Facility
Comprehensive 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.