This SOP defines how to identify, assess, and report serious breaches of GxP or protocol that may significantly impact subject safety or data integrity.
It ensures compliance with ICH and EMA/FDA GxP requirements for breach reporting.
The SOP is fully written and 99 % complete, designed for immediate implementation in biotech and clinical operations.
Includes:
•Definition and classification of serious breaches
•Reporting timelines and communication pathways
•Root-cause investigation and CAPA linkage
•Roles and responsibilities of QA and management
•Documentation and recordkeeping templates
This procedure enables rapid, compliant handling of serious breaches and ensures transparent communication with regulators and sponsors.