Cell Bank Characterization and Adventitious Agent Testing Inspection

Inspection template for verifying master and working cell bank characterization, including identity, purity, sterility, mycoplasma, and adventitious agent testing controls.

Inspection Scope and Cell Bank Identification

• Cell bank type identified as MCB or WCB
• Bank lot, passage, and container identifiers match approved records
• Inspection scope references the approved characterization protocol or SOP
• Chain of custody and sample traceability are documented from bank to test lab
• Inspection date and reviewer are recorded

Identity and Purity Characterization

• Identity test method is defined and approved
• Identity result confirms the bank matches the reference cell line
• Purity assessment performed for cross-contamination or mixed population
• Morphology, growth characteristics, or marker profile are consistent with the intended cell line
• Any identity or purity discrepancy has documented investigation and disposition

Sterility and Mycoplasma Testing

• Sterility test was performed on the required bank sample set
• Sterility result is negative / within acceptance criteria
• Mycoplasma test was performed using an approved method
• Mycoplasma result is negative / within acceptance criteria
• Any out-of-specification or invalid sterility/mycoplasma result has documented retest or deviation handling

Adventitious Agent and Viral Safety Panel

• Testing panel includes the required adventitious agent assays for the cell bank type
• Viral screening or detection methods are approved and fit for intended use
• Results show no detected adventitious agent contamination
• Positive and negative controls met acceptance criteria
• Any detected signal, inconclusive result, or assay failure has documented investigation and disposition

Review, Deviations, and Release Decision

• All required test reports are present, legible, and signed or approved
• Deviations, OOS, or atypical findings are documented with impact assessment
• Final release, rejection, or restricted-use decision is documented
• Quality unit or authorized reviewer approval is recorded
• Follow-up actions and due dates are assigned for any deficiency