Ignite Your Commercial Manufacturing Journey
GMP Spark
We provide flexible, cost-effective and cGMP compliant manufacturing space to support Irish Lifescience companies to launch, grow and scale quickly.
We provide expertise across the entire value chain for companies on their Journey from Product Development, through Clinical Trials and on to Commercialization.
At GMP Spark, we pride ourselves on our unique offering and provide exceptional value and quality compliance levels.
Our attention to detail is second to none from the initial discussions to client onboarding and manufacturing. GMP Spark is setting the bar for innovation and delivery in an ever-evolving industry.
Feel free to contact us for details on locations, release dates, lease rates, and any other questions you may have.
Services Included
When you lease cleanroom space in our facility we provide all the Cleanroom, Facility, HVAC, Utility, 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.
We operate a centralized management and a decentralized operations model to ensure cost efficiency and regulatory compliance. We partner with qualified vendors for any support activities not performed in-house.
ISO Certified Cleanrooms
Modular Design
Our Cleanrooms are designed and built using the latest technology and standards. Our modular approach allows us to quickly expand manufacturing as required. 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.
GxP Compliant Electronic 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
We take care of all Supply Chain and Warehousing operations on our enterprise-grade ERP 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.
Basic Quality Control Testing
QC Testing
We perform all Environmental and Critical Utility Monitoring in-house to ensure compliance with regulated standards. We can perform additional basic QC 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
Validation
We ensure ongoing compliance to regulatory standards by performing Periodic Reviews and Periodic Revalidation on all systems, including requalification of the Cleanrooms, Bio Safety Cabinets (BSCs) Incubators, Fridges, Freezers, and Liquid Nitrogen freezers. We can support your validation efforts also.