A requirement, from the design stage
Quality and innovation
Standards targeted
The project is working towards compliance with the following standards. None is yet held: certification is earned on a plant that has been built and inspected.
- WHO good manufacturing practices
- PIC/S guide, the reference for international pharmaceutical inspections
- ICH guidelines: active substances (Q7), quality risk management (Q9), pharmaceutical quality system (Q10)
- ISO standards for cleanrooms and aseptic processing, for injectables
- Product registration with ARMED, the Angolan medicines authority
Innovation
Living Building Challenge
The environmental standard chosen for the design of the site.
Digital twin
A digital model of the plant, to steer production and maintenance.
Traceability and serialisation
Batch tracking through to distribution, and the fight against falsified medicines.
Connected plant and supply chain
Digital management of flows, from the port of Lobito to distributors.
A question about quality? Write to us →