Run Cell Bank Characterization and Adventitious Agent Testing Inspection — Free

Inspection Scope and Cell Bank Identification

Cell bank type identified as MCB or WCB critical (required)

Note (optional)

Bank lot, passage, and container identifiers match approved records critical (required)

Yes No N/A

Inspection scope references the approved characterization protocol or SOP critical (required)

Yes No N/A

Chain of custody and sample traceability are documented from bank to test lab critical (required)

Yes No N/A

Inspection date and reviewer are recorded

Note (optional)

Identity and Purity Characterization

Identity test method is defined and approved critical (required)

Yes No N/A

Identity result confirms the bank matches the reference cell line critical (required)

Yes No N/A

Purity assessment performed for cross-contamination or mixed population critical (required)

Yes No N/A

Morphology, growth characteristics, or marker profile are consistent with the intended cell line

Yes No N/A

Any identity or purity discrepancy has documented investigation and disposition critical (required)

Yes No N/A

Sterility and Mycoplasma Testing

Sterility test was performed on the required bank sample set critical (required)

Yes No N/A

Sterility result is negative / within acceptance criteria critical (required)

Yes No N/A

Mycoplasma test was performed using an approved method critical (required)

Yes No N/A

Mycoplasma result is negative / within acceptance criteria critical (required)

Yes No N/A

Any out-of-specification or invalid sterility/mycoplasma result has documented retest or deviation handling critical (required)

Yes No N/A

Adventitious Agent and Viral Safety Panel

Testing panel includes the required adventitious agent assays for the cell bank type critical (required)

Yes No N/A

Viral screening or detection methods are approved and fit for intended use critical (required)

Yes No N/A

Results show no detected adventitious agent contamination critical (required)

Yes No N/A

Positive and negative controls met acceptance criteria critical (required)

Yes No N/A

Any detected signal, inconclusive result, or assay failure has documented investigation and disposition critical (required)

Yes No N/A

Review, Deviations, and Release Decision

All required test reports are present, legible, and signed or approved critical (required)

Yes No N/A

Deviations, OOS, or atypical findings are documented with impact assessment critical (required)

Yes No N/A

Final release, rejection, or restricted-use decision is documented critical (required)

Note (optional)

Quality unit or authorized reviewer approval is recorded critical (required)

Follow-up actions and due dates are assigned for any deficiency

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Run: Cell Bank Characterization and Adventitious Agent Testing Inspection

Inspection Scope and Cell Bank Identification

Identity and Purity Characterization

Sterility and Mycoplasma Testing

Adventitious Agent and Viral Safety Panel

Review, Deviations, and Release Decision

Get your results