citec ing - presentacion corporativa
TRANSCRIPT
Mission Statement
TO SERVICE THE PHARMACEUTICAL INDUSTRY IN LATIN AMERICA”
CITEC INGAIMS TO BECOME
THE LEADING FULLINTEGRATED FIRM
Overview
CITEC ING is a Mexico City based firm that provides special-ized 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 cap-ital 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.
We have consolidated our path as the leader in equipment, area qualification, process validation, project management and leasing space drug stability.
CITEC ING was formed in 2003 to provide support to the Health Services industry.
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 prod-ucts in Latin America.
History
QUALIFICATION & VALIDATION
Our Services
PROJECT MANAGMENT
STABILITY
TRAINING
DEVELOPMENT & VALIDATION OF ANALYTICAL METHODS
QUALIFICATION & VALIDATION
QUALIFICATION & VALIDATION
Robust evidence supports our protocols for regulatory compli-ance and auditing, which are created in order to attain a sub-stantial 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
Validation
Specification of required users Commisioning
Validation of the process
Specification of functionality (FS) Qualification of instalation (IQ)
Validation of thermic fabric
Specification of design (DS) Proof of acceptance in factory and fabric (PAF/PAS)
Validation of cleansing
Risk Analysis (RA) Qualification of operation (OQ)
Validation of frozen chain
Proof of acceptance in the factory (FAT) Qualification of performance (PQ)
Validation of computer systems
Proof of acceptance on site (SAT) Re qualification/Re validation
SOME OF OUR CLIENTS
PROJECTMANAGEMENT
Our model is based on the PMBOK of Project Management Institute (PMI)
PROJECT MANAGMENT
The team of CITEC ING has been able to leverage their exper-tise to form a new approach of project management that en-sures efficiency and reliability.
Our model of services and projects of validation assures suc-cessful and timely projects, developing CITEC ING through a innovative technical and administrative path to handle our proj-ects and services.
PROPRIETY MANAGEMENT MODEL FOR VALIDATION
STAFF
SPECIAL PROJECTS
TECHNOLOGY
LEADERSHIP & CHARACTER
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.
All of our staff members have been tested by a physcometric exam and assessed in a technical interview in order to etab-lish utmost efficiency within the company. Our proeficent infra-structure also ensures productivity and teamwork.
STAFF
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 docu-mentation 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 in-struments with traceability CENAM/NIST, electonic bibilogra-phies that are used for consulting in our projects, high resolout-ion photographic cameras, personal laptops, updated software, phonelines, radios of communication etc.
SPECIAL PROJECTS
CITEC ING understands their duty and responsibility to their cli-ents 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 se-curity 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.
TECHNOLOGY
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 proj-ects 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 en-sures quality and productivity of our projects.
LEADERSHIP & CHARACTER
SOME OF OUR CLIENTS
Vetmedica
STABILITY
ICH / NOM – 073
STABILITY
CITEC ING offers to different industries:
Accomodation of their products with climatized cham-bers in the following conditions:
It is a requisite the realization of stability of the medi-cines that commercialize in the country
Temperature
Humidity
Light
For the amount of time that require the studies.
Contingency policies
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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
Diversity of conditions 1 chamber= 1 condition CITEC ING = Various conditions
BENEFITS
Maximize resource materials and huamans of each of the com-panies
Make more efficient the staff without maintenance cost
Flexibility and scalability,
Increment the capability to absorb immediate fluctuations of volume
SOME OF OUR CLIENTS
TRAINING
Validation of processes
Validation of computerized systems
Good practices of fabrication, documentation, laboratiry and storing.
Systems of quality control ISO 9001:2008
Design and application of system documentation
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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SOME OF OUR CLIENTS
DEVELOPMENT & VALIDATION OF ANALYTICAL METHODS
We develope protocols and reports of validation for analitical methods
We train in development and validation of analitical methods
SERVICES
We develope analitical methods in the clients premisis
We validate analitical methods in the clients premisis
We advise on validation of analitical methods
Personal Training
Valida/on of Anali/cal Methods
Development of Anali/cal Methods
PERSONAL TRAININGOF ANALITICAL METHODSDEVELOPMENT
VALIDATION OFANALITICAL METHODS
DEVELOPMENT OF ANALITICAL METHODS
Development of analitical methods in the premisis of the client, while ad-justing to their time and resources
We designed a method that is permitted according to the physiciochemi-cal 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
SOME OF OUR CLIENTS
Ignacio Zaragoza No. 2, Col. EL Mirador. Tlalnepantla, Edo. de México.
Tels: 01(33) 89 95 16 59
Tels: +52 (55) 53 62 61 41 +52 (55) 53 61 03 12
Av. México No. 2798 , 5° Piso BOficina: No 2Col. Arcos de Vallarta, C.P 44680Guadalajara Jalisco.
Contact us OFFICES METROPOLITAN AREA, MÉXICO
OFFICES GUADALAJARA
www.citec.com.mx
www.citec.com.mx