Quality Directorate includes Quality Assurance, Quality Control 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 and Regulatory compliance, which cannot be proven better than the Company’s performance on the regular inspections by the Hungarian National Institute of Pharmacy and Nutrition.
CF Pharma site’s quality management system fully compliant with GMP for APIs (ICH Q7, EudraLex Volume 4 Part II.) and has been successfully inspected by the Competent Pharmaceutical Authority (OGYÉI) since 2003. The last regular OGYÉI inspection was performed in 2022. Furthermore, our customers regularly visit our facility to verify our GMP compliance. The above mentioned audit and inspection program, ensure the constant improvement of our quality management system and the adoption of the most recent industrial trends.
The main task of the Quality Control laboratory is to support GMP productions, check the quality of raw materials, intermediates and final APIs; performing in-process control and release tests, measuring cleaning samples. In addition, stability studies, stress tests and forced degradation studies are also performed in compliance with the general pharma regulation. Our laboratory complies with cGMP standards and operates based on the recommendations of international guidelines (ICH, EMA, EudraLex). We are very proud of our scientific cooperation with EDQM.
The computerized systems ensure full data integrity in compliance with 21CFR Part11. Our well-equipped instrument park and experienced analysts provide contractual partners with the provision of analytical services.
- HPLC unit with UV detect
- HPLC with mass detector
- GC unit with direct injection
- GC unit with headspace unit for residual solvents
- GC unit with direct injection and headspace unit
for residual solvents with mass detector
- UV spectrophotometer
- FT-IR spectrophotometer
- Malvern Mastersizer for particle size determination
- Melting Point Apparatus
- Potentiometric titrator
- Karl-Fischer (volumetric) titrator
- Stability Test Chambers
- Lab equipment (pH-meter, conductometer, heating plates)
- Related substances
- Residual solvents
- Karl Fisher water content
- Sulphate ash content
- Loss on drying
- Optical rotation
- Particle size distribution
- Stability storage
Our on-site Regulatory Affairs team provide regulatory support by preparing and maintaining
regulatory documentation for product registration and life-cycle managements, such as:
- Drug Master Files (DMFs in Europe, Japan, Brazil, etc.)
- Certificates of Suitability (CEP)
- Advice on registration procedures during the product life cycle
- Variations and renewals to existing Marketing Authorization
- Responses to Deficiency Letters during assessment procedure
CF Pharma has already accepted regulatory dossiers by different authorities worldwide
(Europe, Japan, Brazil, Malaysia, South Africa, etc.).