OEM/ODM Manufacturing
Production process control - Pilot batches - Industrial scalability
SOP-driven production with lot accountability and documented release.
Technical request→R&D→Pilot batch→Manufacturing→•Process control→Traceability & retention
OEM/ODM Manufacturing
OEM/ODM manufacturing with SOP-driven operations.
- Long-term OEM production
- Process with technical records
- Strict control & traceability
Pilot batch to scale-up
Pilot production and expansion to industrial output.
- Pilot batch production
- Industrial development
- Scale-up manufacturing
Process control
Standardized production steps and technical approvals.
- Standardized SOPs
- Fixed parameters
- On-site QC/QA
Scale-up
Pilot batch to industrial manufacturing
- Role & function
- Pilot batch execution
- Industrial development
- Large-scale production
- Scale-up manufacturing
Documentation
Each production lot has a lot code, batch records, QC/QA workflow, and traceability records.
- Every lot has a lot code
- Periodic record review
- Release documentation
- No deviation from source records
- Connected departments aligned to SOP