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Run: Viral Clearance Validation Study Protocol Inspection

Use this Viral Clearance Validation Study Protocol Inspection template to verify the study plan, virus panel, sampling, LRV calculations, and deviation handl...

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Study Scope and Protocol Control

Protocol title, version, and effective date are documented critical (required)

Study objective clearly states viral clearance validation across defined purification steps critical (required)

Yes No N/A

Product, process, and manufacturing scale are identified critical (required)

Referenced governing documents include ICH Q5A(R2) and applicable internal SOPs critical (required)

Yes No N/A

Study roles and approvals are assigned to qualified personnel

Yes No N/A

Virus Panel and Spiking Strategy

Virus panel includes relevant model viruses representing different physicochemical properties critical (required)

Note (optional)

Virus stock identity, passage history, and titer are documented critical (required)

Spiking point and target spike ratio are defined for each challenged unit operation critical (required)

Spike recovery and hold-time controls are included where applicable

Yes No N/A

Virus handling and containment controls are defined for the study critical (required)

Yes No N/A

Purification Steps and Orthogonal Clearance Claims

Each purification step evaluated for viral clearance is listed in process order critical (required)

Orthogonal clearance mechanisms are identified across steps critical (required)

Note (optional)

Worst-case operating conditions are justified for each challenged step critical (required)

Yes No N/A

Process parameters affecting clearance are specified with acceptable ranges

Inactivation and removal claims are not conflated in the protocol critical (required)

Yes No N/A

Sampling, Assay Controls, and Analytical Method

Pre- and post-step sample points are defined for each clearance unit operation critical (required)

Sample volumes, dilution scheme, and storage conditions are specified critical (required)

Assay method is qualified or validated for the intended matrix critical (required)

Yes No N/A

Assay controls include positive control, negative control, and matrix interference assessment critical (required)

Note (optional)

Limit of detection and limit of quantitation are documented for the assay

Log-Reduction Calculations and Data Integrity

LRV calculation method is defined for each step and for cumulative clearance critical (required)

Treatment of values below the assay detection limit is defined critical (required)

Yes No N/A

Replicate handling and averaging rules are specified

Yes No N/A

Raw data, calculations, and audit trail are retained and traceable critical (required)

Yes No N/A

Deviations, Acceptance Criteria, and Final Report

Acceptance criteria for each clearance step and cumulative LRV are predefined critical (required)

Protocol deviations and out-of-trend results require documented assessment critical (required)

Yes No N/A

Final report includes conclusion on viral clearance adequacy and study limitations critical (required)

Yes No N/A

Final report is reviewed and approved by authorized quality and technical signatories critical (required)

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