The Practicalities of Biospecimen Storage & Good Storage Practice

1. IUSM Bio Repository Tissue Bank SymposiumDr. F. John MillsCEO – BioStorage TechnologiesIU Med Center CampusThursday, December 4th, 2008

2. The Practicalities of Biospecimen Storage & Good Storage Practice • The Good, The Bad and The Ugly • GXP / GTP • GSP

3. What do poorly maintained repositories look like? Adequate Ventilation?

4. What do poorly maintained repositories look like? The Corridor Syndrome… Electrical Safety?

5. What do poorly maintained repositories look like?

6. What do poorly maintained repositories look like? Inventory Control?

7. What do well-organized repositories look like? • Space • Ventilation • Safe Wiring Inventory Control

8. What do well-organized repositories look like? Temperature Monitoring / Sample Integrity Redundancy

9. 21 CFR Part 1270, 21 CFR Part 1271 – Good Tissue Practice: GTP Compliance (effective May 25th, 2005) • GTP is meant to ensure the safety of HCT/Ps by preventing the introduction, transmission and spread of communicable disease  Infected Allografts have caused major concerns. • There shall be written procedures prepared and followed for all significant steps. • Records shall be maintained concurrently with the performance of each significant step “The records shall identify the person performing the work, the dates of the various entries and shall be detailed as necessary to provide a complete history.”  Audit Trail (ideally automated and 21 CFR Part II Compliant)

10. 21 CFR Part 1270, 21 CFR Part 1271 – Good Tissue Practice GTP Compliance (cont) • Document and maintain records of the use of each piece of equipment  Proof of Freezer Maintenance (as per manufacturer) • “Records pertaining to a particular HCT/P must be maintained in such a way as to facilitate review of the HCT/Ps history before making it available for distribution.”  Audit Trail  Temperature records to prove integrity (including during shipment)

11. 21 CFR Part 1271.160 Subparts D • Establishments that perform any step in the manufacture of HCT/Ps must establish and maintain a quality program. • Ensuring that appropriate corrective actions relating to core CGTP requirements, including re-audits of deficiencies. • Quality audit must be periodically performed. • Validate computer software for intended use…if you rely upon the software to comply with core CGTP requirements.

12. Some Thoughts On “Good Storage Practice” Safety • Electrical • GLP standard personal protection – gloves, goggles, etc. (GLP) • Closed containers • Staff training (GLP) • Smoke Detection/Fire Suppression systems • Controlled access, video surveillance, etc. Cold Chain Logistics • Chain of custody • Validated insulated boxes • In-transit temperature monitoring

13. Some Thoughts On “Good Storage Practice” 21 CFR PT 11 Validated Inventory System • Complete audit trail • Rapid access to data associated with samples Temperature Integrity • Validated WIPs • Constant temperature monitoring • Full temperature history Business Continuity • Backup power • Freezer redundancy • HVAC redundancy • Full BC & disaster recovery plans

14. Some Thoughts On “Good Storage Practice” • Good storage practice also means good scientific practice • Good scientific practice is good ethical practice