Technology
Manufacturing you can document to a regulator
A product that cannot be documented cannot be registered, and a product that cannot be registered cannot be sold. Our manufacturing process is built around the documentation trail as much as around the product.
How manufacturing runs
- 01
Specification
Product requirements, claims, volumes and territories defined in writing.
- 02
Component qualification
Sourcing, incoming inspection, supplier records.
- 03
Pilot lots
Manufactured and verified by you before scale-up.
- 04
Production and release
QC testing against defined acceptance criteria, batch release.
- 05
Stability
An ongoing programme, not a single study.
- 06
Supply
Rolling manufacture against your forecast, with contracted lead times.
What you receive with every lot
- Batch records
- Certificates of analysis
- Component traceability
- Release testing data
Quality system
Our quality management system covers documentation control, SOPs, change control, deviation handling and audit readiness.
Current status:[QUALITY STANDARD - certification status and date]
Customer audit rights are available under supply agreements - we would rather you inspect than assume.
Design transfer
Where we develop a product for you, the design history file inputs, bill of materials, instructions for use and labelling are delivered as part of the transfer. If you later choose to manufacture elsewhere, that package goes with you. We think that is the correct commercial posture, and it is written into our agreements.
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