Tech Transfer Checklist: From Lab to Commercial Scale

Tech Transfer Checklist: From Lab to Commercial Scale

Pre-Transfer Phase

Documentation Requirements

• Process development reports
• Analytical method validation
• Stability data package
• Regulatory filings

Team Setup

• Transfer team identified
• Roles and responsibilities defined
• Communication plan established

Transfer Phase

Knowledge Transfer

• Process understanding sessions completed
• Critical parameters documented
• Historical data reviewed

Equipment Qualification

• Equipment identified and procured
• IQ/OQ protocols approved
• Equipment qualified

Process Validation

• Validation protocol approved
• PPQ batches completed
• Validation report approved

Post-Transfer Phase

• Continued process verification plan
• Stability monitoring initiated
• Commercial readiness confirmed