COLD CHAIN


· ·


Emergency response planning 21 CFR, Part 11-compliant monitoring


• Quality systems · · ·


· Documentation of current Good Practices Audits: records of temperature, access and inventory control


Adequate safety measures for the type of materials stored: biological, chemical electrical fire, physical, liquid nitrogen


Training program and documentation » Training records documenting frequency of training


» Cross-training to adequately train employees on security, continuity, inventory policies and procedures


• Record retention ·


Availability for audits and inspection


• Inventory systems · · · · · · ·


Current GMP-compliant storage Location system Lot control


Audit trail/tracking Labeling Barcoding


Temperature/humidity tracking and records


• Shipping conditions · ·


Comprehensive data monitoring Availability of data records to validate temperature controls


Verifiable Biostorage and Fulfillment Capabilities


When planning for commercialization of a cell-based therapy, a biopharma company should confirm that a prospective logistics management partner has advanced, GMP-compliant cryogenic storage and fulfillment capabilities, as these are essential to maintaining product quality while accommodating shipping timelines and workflow and inventory management for sponsors, investigators and researchers. GMP-compliant facilities and knowledgeable staff can facilitate the transportation of valuable and often irreplaceable time- and temperature-sensitive biologic materials, which may require dedicated shipment and storage to ensure that every shipment reaches its destination securely. Additionally, suppliers with strategically located depots around the world can allow drug developers and marketers to reach emerging markets quickly and cost-effectively.


For many biopharmaceutical companies, the outsourcing decision rests on identifying a full-service provider. When vetting a potential biostorage and fulfillment partner, biopharmaceutical companies would do well to consider the following capabilities:


• Dedicated multi-temperature warehousing, from controlled ambient to deep frozen


• Packaging and radiofrequency identification (RFID) label application


• Quality control systems • Open pallet storage • Independent temperature detection data loggers • Periodic temperature and activity reports • Controlled access to commodities • Commercial drug storage


• 21 CFR, Part 11-compliant accessioning and inventory management


• Capabilities to segregate approved, quarantined and damaged materials


• Kitting services, if required


• Storage capacity for apheresis materials, collection kits and final dose


• Inbound and outbound shipments and tracking • Documentation for shipping and receiving • Agreement on shipment notification periods and lead times • Availability of long-term storage, if required


• Protocols for shipment method and agreement on qualified vendors


• Adequate reporting (at the customer’s required frequency) of: · ·


Lot numbers Expiry information


· Quantities by category; released, quarantined and damaged materials


· Temperature deviations


• Ability to integrate with customer’s proprietary information systems for real-time tracking and reporting


• Labor management systems and processes • 24/7/365 on-site security and alarm response


Suppliers that combine detailed logistics, biostorage and fulfillment capabilities can enable complete control and transparency of material shipment and storage. Those making use of advanced technologies can facilitate planning for an end-to-end solution and compliant workflows that protect materials and patients while providing the information to validate clinical trial data.


“The future is in the technology,” says Lebbin. “Companies seeking to outsource supply chain management should look for logistics and biostorage partners that leverage technological advances to facilitate complete visibility of the entire chain of custody and chain of condition. As the market for cell-based therapies continues to expand, end-to-end biostorage and fulfillment services will become increasingly vital to ensuring successful drug development and commercialization.”


Pharmaceutical Outsourcing | 38 | November/December 2016


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