Genovior provides high quality services for finished products of vials in liquid or lyophilized forms, prefilled syringe, cartridge, and dual chamber syringe/cartridge. PIC/S GMP (cGMP, EU GMP) is strictly followed in our facilities. We can also provide services for development of lyophilization program as well as design of packaging box, labeling of randomized code and labels, and packing of the final product.
PIC/S GMP (cGMP, EU GMP) Production
- PIC/S GMP (cGMP, EU GMP) training
- Equipment validation and calibration
- Process validation
- Documentation control
- Material control
- Product control
- Label control
- Storage and shipment Control
Service
- Vial in liquid form
- Maximum scale: up to 5,000 vials per batch
- Vial Types: 2R, 4R, 20R, 30R or customized
- Fill volume: 0.2 ml to 30 ml
- Vial, stopper and cap: provided by customer or GBC
- QC testing
- Stability study
- Labeling
- Storage and shipment
- Maximum scale: 5,000 2R vials per batch
- Vial types: 2R, 4R, 20R or customized
- Fill volume: 0.2 ml to 20 ml
- Vial, stopper and cap: provided by customer or GBC
- Lyophilization program development
- QC testing
- Stability study
- Labeling
- Storage and shipment
- Types of prefilled syringe: ISO standard 1 ~ 2.25ml or customized
- Fill volume: 0.2 ml to 2.25 ml
- Prefilled syringe/plunger: provided by customer or GBC
- Assembly of syringe/plunger, backstop and plunger rod
- QC testing
- Stability study
- Labeling
- Storage and shipment
- Types of cartridge: ISO standard 3 ml or customized
- Fill volume: upon request
- Cartridge: provided by customer or GBC
- Assembly of cartridge and auto-injector
- QC testing
- Stability study
- Labeling
- Storage and shipment
- Types of dual-chamber prefilled syringe: upon request
- Fill volume: upon request
- Dual-chamber Prefilled syringe/plunger: provided by customer or GBC
- Assembly of syringe/plunger, backstop and plunger rod
- QC testing
- Stability study
- Labeling
- Storage and shipment
- Design of package box
- Composed of package material
- Label of randomized code
- Pack of clinical randomized product
- Storage and shipment