Phase I laboratory investigation and evidence required to establish laboratory error
Phase II review of manufacturing, filling, environmental, personnel, equipment, utilities, and process factors
Contamination-source evaluation using recovered organisms and supporting microbiological evidence
Root cause determination using investigation data, 5 Why, Fishbone, interviews, records, and process review
Investigation scope, affected-batch assessment, and considerations supporting batch disposition
Documenting probable or definitive root cause, corrective actions, CAPA, and inconclusive investigations