CTP SYSTEM Information

CTP Team is composed of Engineers, Chemists, Pharmaceutical experts and Biologists who, through the skills of "in home" expert technicians, manage and perform Qualification activities for all kinds of equipment and systems within the Pharmaceutical Industry and related Industries. Moreover, we have a consolidated expertise in helping our clients solve the problems that frequently arise around documentation deficiencies and other practical aspects. In 2017, CTP SYSTEM enters AKKA TECHNOLOGIES Group, already a leader in Italy and Europe in the development of technology services for the Automotive, Railway, Aeronautics, Space & Defense, Oil & Gas, and with this operation reinforces its growth path in LIFE SCIENCES sector. Specialized in providing GMP Services (Pharmaceutical Engineering & Consulting) for Pharmaceutical, Chemical and Health Industry, CTP SYSTEM continues its quality improvement with the experience that has characterized over 25 years of field activities. VALIDATION and IT COMPLIANCE CTP SYSTEM supports its clients in the management implementation of all the validation phases. CTP performs computer validation of all automated systems form the single equipment control system to the complex Distributed Control Systems (DCS) and the Building Management Systems (BMS). Services: o GAP Analysis o Risk Analysis / Impact Assessment o Design Qualification o Validation Master Plan Preparation o IQ / OQ / PQ of Manufacturing Equipment & Critical System o Analytical Equipment Qualification o Maintenance & Calibration - Metrology Plan - Preventive Maintenance Plan - Troubleshooting - SOPs ENGINEERING Services offered by CTP SYSTEM: o Project Management o Value Engineering o Feasibility Studies o Conceptual, Basic & Detail Design o Manufacturing Equipment & Critical System Supplier Selection o Commissioning o FAT / SAT PROCESS&QUALITY The PROCESS & QUALITY Department has the experience and know-how for companies that require REGULATORY SERVICES, SUPPORT to PRODUCTION DYNAMICS and QUALITY ASSURANCE. REGULATORY AFFAIRS · Regulatory Documentation Preparation · Submission Support · Strategic consulting at European level QUALITY ASSURANCE · Documentation Preparation and Review · Auditing Activity · Risk Management & Risk Analysis · GMP & ISO Consultancy PRODUCTION · Process Development & Scale Up · Technology Transfer · Process & Cleaning Validation · Process Improvement