We take strict measures to ensure that everything we do follows the best practices and standards of the biological storage and logistics industry.
- Process, workflow and systems analysis. Software implementation, data management.
- GDPR – General Data Protection Regulation – compliance, data encryption, sample pseudonymization, real time data visibility.
- Inventory Management, Sample Management, Barcode and RFID Tracking. Repurposing of samples… relabeling and verification. Biorepository, Biostorage Facility Design. Cryogenic storage, Liquid nitrogen storage. Tissue & Cell banking. Master Cell Bank (MCB) development & storage. Distribution of biological samples and biospecimens. Freezer furniture design and interior sample storage strategies. Sample biopreservation and biobanking.
- Biopharmaceutical and cell therapy facility concept & design. Planning and implementation. Vendor analysis and auditing. Equipment and Systems Procurement, Vendor Document Requirements and Document Management. Construction Document Requirements. Commissioning, Qualification, Validation. ASTME E2500 Verification, Critical Process Parameters, Critical Quality Attributes
- Biopharmaceutical, cell therapy, ATMP manufacturing, GMP Compliance, Facility Certification and Approval. Tissue and cell storage and distribution. Stem Cell Storage, Bone Marrow Storage. Regenerative Medicine, Quality Management System Development (ISO or GMP). Clinical Trial Sample Storage, Clinical Trial Sample Kits.
- Good Distribution Practices & Compliance, Auditing & Certification of Transport Providers, Cold Chain Logistics, Cool Chain Logistics. Supply Chain Reliability, Sample Transport. Packaging optimisation, Temperature Controlled Distribution, Cold chain monitoring. GPS Tracking, BREXIT impact on transport and import and export of regulated pharmaceutical products, customs and excise. IATA Dangerous Goods Regulations, CITES Convention on International Trade in Endangered Species, GMO, UN3373 Compliance. WHO Transport Guidance
- Contingency Planning. Risk Analysis, Disaster Recovery Planning, Facility Relocation Projects
- Regulatory Affairs – The EU Tissues and Cells Directives, The General Data Protection Regulation (GDPR), The Clinical Trials Regulations, Advanced Therapy Medicinal Products (ATMP), ABP Regulation
- All equipment, systems, processes are under Change Control, Variance Control and Corrective Action/Preventative Action (CAPA) as applicable and reviewed and approved by the Responsible Person. All storage equipment used at Biostór Ireland is appropriately identified and suitable for its intended purpose and equipment/systems undergo verification and qualification as per the ASTM E2500 risk-based approach. Following Installation Qualification (IQ) and Operational Qualification (OQ) to verify the equipment/systems are in compliance with the User Requirements (URS). The functioning of storage equipment is under continuous Performance Qualification (PQ) and subject to scheduled cleaning & preventative maintenance.
