Quality
Quality is a system, not a final check.
Our approach
Quality Is a System, Not a Final Check
At Grandene, quality is intended to be embedded across the pharmaceutical lifecycle — from supplier qualification and incoming materials to manufacturing controls, testing, documentation, release and continuous improvement.
Our quality organization is being developed around a risk-based, science-led approach with clear responsibilities, controlled documentation and a strong culture of compliance.
Quality across the product lifecycle
- Supplier qualification
- Incoming materials
- Manufacturing controls
- Testing
- Documentation
- Release
- Continuous improvement
Focus areas
Quality system focus areas
Laboratories
Equipped for analytical precision
Our quality control laboratories are equipped with analytical instruments from the United States, Germany, Japan, the United Kingdom and India — supporting reliable testing from incoming materials to finished product.
- USA
- Germany
- Japan
- United Kingdom
- India
A Culture of Quality
Systems alone do not create quality. People do. Grandene is committed to developing a culture in which every employee understands that product quality, patient safety and compliance are shared responsibilities.
GMP & regulatory framework
Built toward recognised GMP standards
Grandene's facility, quality systems and documentation are being developed in line with the following GMP frameworks. Certification status is communicated only after formal approval by the relevant authority.
EU-GMP
European Union Good Manufacturing Practice
EAEU GMP
Eurasian Economic Union GMP requirements
Uzbek GMP
Good Manufacturing Practice of the Republic of Uzbekistan
Building Toward International GMP Expectations
Working with Integria Pharma Hungary