The innovative medicines, whether by gene therapy, stem cells and tissue engineering, and related sectors (transplants, blood, etc.) lay the healthcare facilities facing new challenges: safety and efficacy of the drug and/or tissue, innovative technologies , risk assessment, traceability of the preparation, quality management system and constantly changing regulatory requirements.
CTP SYSTEM's experience, a reference point for the application of GMP in the pharmaceutical field, is able to support the facilities wishing to be approved by the competent Health and Regulatory Authorities.
CTP SYSTEM is the ideal solution and proposes itself as a reliable and flexible partner to better address the organizational, scientific and technological challenges, in order to ensure effective implementation of GMPs for Advanced Therapies.
CTP SYSTEM services:
- Risk analysis and assessment
- Feasibility Studies
- Quality System construction and adaptation
- Design and engineering services
- Qualification and construction of utilities, equipment, clean rooms and IT systems
- Process and cleaning validation
- Support for Health Authorities inspections
- Support for FACT-JACIE certification
- Solutions for environmental monitoring and microbiological tests in GMP
- Consumables and equipment for contamination control
- Product analysis
- Analytical methods validation
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