The Quality department includes: Quality Control, Quality Assurance and Regulatory Affairs units. These separate units jointly ensure to meet the required quality and regulatory provisions of our Customers over the whole manufacturing process.
Based on the national legislation and the international GMP regulations – a thorough quality assurance system has been established and implemented in order to regulate all the quality sensitive methods and processes and to ensure the cooperation and support of the employees at all levels.
Among the greatest strengths of CF Pharma are Quality Assurance and Control and Regulatory compliance, which cannot be proven better than the Company’s excellent performance on the regular inspections by the Hungarian National Institute of Pharmacy and Nutritiony.
Raw materials, intermediate products, active substances and packaging materials are all checked for compliance with specifications. In the pharmaceutical development phase, analytical methods are developed and validated, which includes the characterization of active substances and reference substances as well as stability testing of possible by-products and degradation products based on international guidelines.
- EU-GMP Certificate for 8 APIs
- Japanese Accreditation
- Regularly inspected by Hungarian National Institute of Pharmacy and Nutrition
- HALAL Certificate for 4 APIs
Quality management requires a robust system for the continuous quality improvement, quality assurance and the possibility of the integration of potential cost saving methods. Every deviation regarding the quality is thoroughly investigated by our team of highly skilled professionals in order to ensure the continuous high-quality performance and the undoubtable quality of our products.
The Management distinguishes between preventive and corrective actions, both of which are used in the quality control system in a transparent and open manner by all involved parties. Regular audits and inspections are performed in order to confirm compliance with all applicable customer and regulatory guidelines.
The close collaboration between Regulatory Affairs, Quality Control, Quality Assurance and Research and Development departments allows us to provide the Customers with the documentation required for the submission of registration applications.
We firmly believe that the close cooperation we maintain with our customers and sharing of our experience and different points of view enable us to challenge, maintain and improve our quality system.
Experienced, on-site Regulatory Affairs team ensures regulatory compliance by preparing and maintaining regulatory documentation such as Drug Master Files and CEPs. We provide strong regulatory performance with regulatory agencies around the world.
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