QUALITY MANAGEMENT SYSTEM
The Quality Management System of Galena Pharma ensures the safety and quality of all our manufactured products – compliance throughout the product lifecycle.
CERTIFICATION AND PERMITS
- Industrial manufacture and packaging of pharmaceuticals
- Human investigational medicinal products
- Medical Devices
- Nutritional supplements
- Our Oiva report can be found here.
- Compliance to national food legislation
- Cosmetics
- Compliance to national cosmetics regulation
- Animal feed mixes
- Compliance to animal feed hygiene regulation
QUALITY ASSURANCE
Galena has an experienced quality assurance team that ensures compliance with all our processes and products. Our empoyees are committed to following GMP guidelines thus guaranteeing high-quality product manufacturing.
Our quality assurance operations include comprehensively:
- raw and packaging material sourcing and control
- manufacturing processes and manufacturing process control
- storage and transport
- quality control
- product batch certification and release
- risk assessment and management
- product development and process validations
- pharmacovigilance
QUALITY ASSURANCE SERVICES
We offer our customers several quality management services:
- Annual evaluations
- Audits (GMP, ISO 13485, ISO 17025)
- Compilation of operating instructions and quality managment systems
- Consultation on various quality management matters
For more information, contact our expert or fill the contact form.
