HemaCare Quality Oversight
The critical role that quality plays in the cell therapy landscape will only continue to evolve and gain relevance as a greater number of cellular therapeutics are approved. HemaCare is committed to delivering the highest quality products and services to scientists and clinicians across the globe. Customers can expect HemaCare to continuously improve their processes, products, and services to meet customer needs and regulatory requirements. HemaCare aims to provide optimal starting material so cell therapies continue to reach their market potential and improve patient health.
Quality and consistency of starting material is crucial to the success of cell and gene-based therapies. HemaCare maintains comprehensive validation programs of its facility, equipment, and processes to ensure customers receive consistent, high-quality products. HemaCare’s quality system is based on strict regulatory requirements and industry best practices. The quality system adopted by HemaCare follows the current Good Manufacturing Practices (GMP) guidelines that encompass the systems below:
- Qualification of donors
- Qualification of vendors, equipment, and supplies
- Monitoring equipment, supplies, and environment
- Development, validation, and maintenance of procedures
- Comprehensive staff training and qualification
- Documentation and records management
- Management of deviations and planned variances (exceptions)
- Monitoring quality indicators for continual process improvement
- Internal and external inspections
Licensure and Accreditation
HemaCare complies with documented procedures governing the sourcing, handling, processing, storage, preserving, packaging, and distribution of products. HemaCare is FDA registered (Blood and HCT/P) and meets all applicable GMP/GTP standards (21 CFR 210, 211, 606, 1271 and 21 CFR part 11 and part 58). HemaCare maintains compliance with the State of California Laws and Regulations, meets CLIA requirements to ensure the accuracy and reliability of quality control testing and is AABB accredited, which verifies that an appropriate quality management system and controlled collection processes are in place. In addition to the FDA, HemaCare complies with European Medicines Agency (EMA) guidelines and our GMP-compliant facility is routinely audited by the FDA, State of California, and AABB.
HemaCare’s cGMP-compliant Facility
HemaCare’s state-of-the-art, GMP-compliant facility in Southern California expedites GMP-compliant collection and, coming soon in 2019, cell processing and cell isolation of cellular material. Our operations experts store and ship cellular material using the best-in-class cold chain procedures.
Facility features include:
- FDA registered and State of CA licensed donor collection center
- Four clean rooms qualified in accordance with FDA and EMA guidelines
- Cryogenic storage capacity with controlled access and continuous temperature monitoring
Comprehensive programs for:
- Equipment management
- Supplier/Vendor qualification
- Materials management
- Staff training
- Facility and environment monitoring
Ethics and Informed Consent
HemaCare complies with all applicable local, state, and federal laws and regulations. Cells are obtained from donors who review and sign an IRB-approved informed consent. Biological material is collected, processed, and stored in accordance with the FDA’s GMP, GTP, and GLP requirements. HemaCare’s participation in approved clinical trial collections is conducted in accordance with GCP requirements. Collected material is shipped, used, stored, and destroyed in compliance with all applicable local, state, and federal laws and regulations.
HemaCare supports the development of cell-based therapies from basic research through commercialization. To ensure product integrity is maintained, all critical processes are defined in approved operational procedures. Our team of experts are qualified, trained, and apply the operational excellence needed to ensure the highest quality product possible. HemaCare routinely performs internal audits to ensure compliance in all areas of operation.