Draft an equipment maintenance deviation page in the lab notebook detailing a 2-hour −80 °C freezer temperature excursion impact on retroviral vector aliquots

Supporting Documentation

Deviation Discovery Method * Select discovery method Automated temperature alarm triggered Daily manual temperature log review Visual inspection revealed frost buildup ICL/scheduled freezer check Unexpected sample thaw observed during retrieval Power outage event recorded Equipment malfunction service call Post-incident audit finding Other discovery method

Excursion Duration and Extent *

Impacted Retroviral Vector Details *

Intended Study Use and Criticality * Select downstream use GLP toxicology study for IND filing GMP clinical trial material backup Research-only transduction experiments Vector standard qualification runs Stable cell line generation for reference standards Pre-clinical efficacy screening Regulatory authority requested retention samples Investigator-initiated clinical research Process development validation studies Not yet assigned to specific study

Immediate Containment Actions * Select containment action Transferred to validated backup −80 °C freezer Moved to vapor phase liquid nitrogen storage Segregated to designated quarantine freezer Left in original freezer after repair/recalibration Distributed across multiple backup freezers Relocated to external biorepository Scheduled for immediate use under deviation protocol Stored temporarily in −20 °C pending disposal authorization Maintained in original location with continuous monitoring Other containment action taken

Regulatory Notification Requirements * Select notification requirement FDA deviation report within 72 hours (IND safety reporting) EMA notification required for IMP collection IRB/IEC notification within 24 hours for research Internal QMS deviation system only Commercial sponsor notification required CDSCO reporting for India-imported vectors TGA Australia notification if matrix shipped Health Canada reporting if Canadian sites involved No external notification required (research only) Vendor/supplier notification per contract terms

Stability Assessment Criteria * Select stability criteria ICH Q5C biologics stability guidelines FDA gene therapy CMC guidance vector storage Internal validated stability program criteria Ph. Eur. 5.2.12 generalized storage claims Accelerated stability study data (internal) Vector-specific potency assay correlation data Peer-reviewed literature evidence for similar vectors Matrix-based formulation stability references Vendors' validated storage stability claims Risk-based assessment with functional verification required

Risk Assessment Factors *

Supporting Laboratory IDs *