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VALIDATION

CTP SYSTEM supports its clients in the management implementation of all the validation phases.

CTP has extensive experience in the preparation of Validation Master Plans at all levels, on both a site wide or individual project basis and on behalf of the main international companies for all types of pharmaceutical products (APIs, solid and liquid form, sterile products and more).

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).

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.

Services offered by CTP SYSTEM:
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
    - Specialised services (vacuum, thermography...)
    - Troubleshooting
    - SOPs

 

DOWNLOAD

CARD Validation

21.05.2010
AGREEMENT CTP SYSTEM - BUENOS AIRES

 

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CTP SYSTEM IN ETIF 2010

 

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GXP TRAINING: MULTI-USER COURSES 2010

 

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