Mission Statement
CITEC ING AIMS TO BECOME THE LEADING FULL INTEGRATED FIRM
TO SERVICE THE PHARMACEUTICAL INDUSTRY IN LATIN AMERICA”
Overview CITEC ING is a Mexico City based firm that provides specialized services to the pharmaceutical, chemical, cosmetic and hospital industries. The company is comprised of five business units to provide these services efficiently to their clients. Through experience, technology, efficiency, qualified staff and teamwork, CITEC ING has been able to create strong relations with its clients from the services that it provides. Along with these positive attributes, CITEC ING received a capital commitment in 2012 from Beamonte Investments, a firm that is based in Boston, Massachusetts. It is one of the leading investment firms in the world and has allowed CITEC ING to grow exponentially since their partnership.
History
CITEC ING was formed in 2003 to provide support to the Health Services industry. We have consolidated our path as the leader in equipment, area qualification, process validation, project management and leasing space drug stability. In 2011 we were looking to innovate through technology and therefore created a strategic alliance with ELLAB INC, where we became the exclusive distributors of their high quality products in Latin America.
Our Services
QUALIFICATION & VALIDATION PROJECT MANAGMENT STABILITY TRAINING DEVELOPMENT & VALIDATION OF ANALYTICAL METHODS
QUALIFICATION & VALIDATION
QUALIFICATION & VALIDATION Robust evidence supports our protocols for regulatory compliance and auditing, which are created in order to attain a substantial standard of qualification and validation for equipment and systems within the pharmaceutical industry. We have developed a complete life cycle for each equipment and system, as this is a prerequisite to acheive considerable standards of qualification for our products and services.
LIFE CYCLE Pre requisites
Qualification
Specification of required users Specification of design (DS) Specification of functionality (FS) Risk Analysis (RA)
Commisioning Proof of acceptance in factory and fabric (PAF/PAS) Qualification of instalation (IQ) Qualification of operation (OQ)
Proof of acceptance in the factory (FAT) Proof of acceptance on site (SAT)
Qualification of performance (PQ) Re qualification/Re validation
Validation Validation of the process Validation of cleansing Validation of thermic fabric Validation of frozen chain Validation of computer systems
SOME OF OUR CLIENTS
PROJECT MANAGEMENT
PROJECT MANAGMENT The team of CITEC ING has been able to leverage their expertise to form a new approach of project management that ensures efficiency and reliability.
Our model of services and projects of validation assures successful and timely projects, developing CITEC ING through a innovative technical and administrative path to handle our projects and services. Our model is based on the PMBOK of Project Management Institute (PMI)
PROPRIETY MANAGEMENT MODEL FOR VALIDATION
STAFF
LEADERSHIP & CHARACTER
TECHNOLOGY
SPECIAL PROJECTS
Our staff is qualified to provide the services and handle the products of CITEC ING. Each individual is highly motivated with a mentality to fulfill our clients’ needs.
STAFF
All of our staff members have been tested by a physcometric exam and assessed in a technical interview in order to etablish utmost efficiency within the company. Our proeficent infrastructure also ensures productivity and teamwork.
SPECIAL PROJECTS
Through the use of several means of technology, CITEC ING is able to reach high levels of productivity from its products and services. Primarily, the use of protocols and standardized documentation maintains CITEC ING’s efficiency throughout all of its operations. Also, our use of innovative technology enable us to attain high standards of quality. For example, medical equipment and instruments with traceability CENAM/NIST, electonic bibilographies that are used for consulting in our projects, high resoloution photographic cameras, personal laptops, updated software, phonelines, radios of communication etc.
TECHNOLOGY
CITEC ING understands their duty and responsibility to their clients and will go the extra mile in order to fulfill their needs. We encourage effective communication with out clients in order to achieve this goal and we highly value the confidentiality and security of the information that our clients trust to share with us. Our team maintains a hardworking and motivated attitude, along with the belief in the benefits of working in a team. We are confident that our work ethic allows us to be successful in our projects and deliver to the needs of our clients.
LEADERSHIP & CHARACTER
CITEC ING has developed a proprietory management system for its projects in order to achieve its objective efficiently. This innovative management system ensures quality for the projects that we acquire. In order to achieve consistency we utilize a manual for our projects to standardize our services. We use a support service system that accompanies our auditing services, which also ensures quality and productivity of our projects.
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Vetmedica
STABILITY
STABILITY CITEC ING offers to different industries:
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Accomodation of their products with climatized chambers in the following conditions: › Temperature › Humidity ›
Light
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For the amount of time that require the studies.
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Contingency policies
ICH / NOM – 073
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It is a requisite the realization of stability of the medicines that commercialize in the country
CONDICIONES DE OPERACIÓN 30 °C ± 2 °C / 35 % ± 5 % HR 40 °C ± 2 °C / 75 % ± 5 % HR 30 °C ± 2 °C / 75 % ± 5 % HR DE 30 °C A 80 °C BAJA TEMPERATURA, HASTA 25 °C 5 °C ± 3 °C / HA 30 °C ± 2 °C / 65 % ± 5 % HR TEMPERATURA VARIABLE 25 °C ± 2 °C / 60 % ± 5 % HR
BENEFITS Maximize resource materials and huamans of each of the companies Make more efficient the staff without maintenance cost Flexibility and scalability, Increment the capability to absorb immediate fluctuations of volume Diversity of conditions 1 chamber= 1 condition CITEC ING = Various conditions
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TRAINING
TRAINING The staff that does our courses have an extensive background, not only as trainers but also in the industry Some of our courses:
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Validation of processes
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Systems of quality control ISO 9001:2008
Validation of computerized systems Good practices of fabrication, documentation, laboratiry and storing. Design and application of system documentation
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DEVELOPMENT & VALIDATION OF ANALYTICAL METHODS
SERVICES We develope analitical methods in the clients premisis We validate analitical methods in the clients premisis We develope protocols and reports of validation for analitical methods We advise on validation of analitical methods We train in development and validation of analitical methods
DEVELOPMENT
PERSONAL TRAINING
OF ANALITICAL METHODS
VALIDATION OF ANALITICAL METHODS
DEVELOPMENT OF ANALITICAL METHODS Development of analitical methods in the premisis of the client, while adjusting to their time and resources We designed a method that is permitted according to the physiciochemical characteristics for the matter in determination and quanitification
VALIDATION OF ANALTICAL METHODS Validation of analitical methods in the premisis of the client adjusting to their needs It is the process by which the laboratory establishes the characteristics of its performance of methods. These characteristics meet the analitcial applications that have been previously identified
PRODUCTS
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Contact us
OFFICES METROPOLITAN AREA, MÉXICO Ignacio Zaragoza No. 2, Col. EL Mirador. Tlalnepantla, Edo. de México. Tels: +52 (55) 53 62 61 41 +52 (55) 53 61 03 12 www.citec.com.mx
OFFICES GUADALAJARA Av. México No. 2798 , 5° Piso B Oficina: No 2 Col. Arcos de Vallarta, C.P 44680 Guadalajara Jalisco. Tels: 01(33) 89 95 16 59 www.citec.com.mx