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