Ten Organizational Design Models to align structure and operations to busines...
CITEC ING - Presentacion Corporativa
1.
2. Mission
Statement
CITEC ING
AIMS TO BECOME
THE LEADING FULL
INTEGRATED FIRM
TO SERVICE THE PHARMACEUTICAL INDUSTRY IN LATIN AMERICA”
3. 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.
4. 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 prod-
ucts in Latin America.
5. Our
Services
QUALIFICATION & VALIDATION
PROJECT MANAGMENT
STABILITY
TRAINING
DEVELOPMENT & VALIDATION OF ANALYTICAL METHODS
7. 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.
8. LIFE CYCLE
Pre requisites Qualification
Specification of required users Commisioning
Specification of design (DS) Proof of acceptance in factory and fabric (PAF/PAS)
Specification of functionality (FS) Qualification of instalation (IQ)
Risk Analysis (RA) Qualification of operation (OQ)
Proof of acceptance in the factory (FAT) Qualification of performance (PQ)
Proof of acceptance on site (SAT) Re qualification/Re validation
Validation
Validation of the process
Validation of cleansing
Validation of thermic fabric
Validation of frozen chain
Validation of computer systems
11. 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.
Our model is based on the PMBOK of Project Management
Institute (PMI)
13. 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 etab-
lish utmost efficiency within the company. Our proeficent infra-
structure also ensures productivity and teamwork.
14. 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.
SPECIAL
PROJECTS 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.
15. 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.
TECHNOLOGY
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.
16. 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-
LEADERSHIP ects that we acquire.
& CHARACTER 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.
19. STABILITY
CITEC ING offers to different industries:
° Accomodation of their products with climatized cham-
bers in the following conditions:
› Temperature
› Humidity
› Light
° For the amount of time that require the studies.
° Contingency policies
ICH / NOM – 073
° It is a requisite the realization of stability of the medi-
cines that commercialize in the country
20. 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
21. 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
Diversity of conditions
1 chamber= 1 condition
CITEC ING = Various conditions
24. TRAINING
The staff that does our courses have an extensive background,
not only as trainers but also in the industry
Some of our courses:
° 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
27. 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
28. DEVELOPMENT PERSONAL TRAINING
OF ANALITICAL METHODS
VALIDATION OF
ANALITICAL METHODS
29. 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
30. 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
