All manufacturing services
Manufacturing
Process Transfer & Pilot Trials
Laboratory or pilot work to establish the process basis before larger-scale trials and commercial operating conditions are proposed.
Use case
Confirm that a process transferred from another site, country or CDMO can be replicated before larger campaigns or regulatory filings.
Customer inputs
- Transfer package: batch records, SOPs, analytical methods
- Critical process parameters and proven acceptable ranges
- Raw-material specifications and alternate suppliers
- Previous campaign data for comparison
- Success criteria for trial lots
Execution
- Document review and structured gap assessment
- Method transfer or equivalency testing plan
- Laboratory or mini-pilot replication if gaps exist
- Trial batch at target commercial scale
- Side-by-side comparison to historical lots
- Close gaps; update batch record and training records
Responsibilities
- Customer: approves CPP ranges and specification equivalence
- Receiving site: executes trial and documents deviations
- Chemlyst: facilitates transfer meetings, scheduling and action tracking
Deliverables
- Transfer gap assessment with prioritized actions
- Trial batch records and analytical comparison table
- Updated master batch record or change control
- Written go / no-go for commercial campaigns