| |
 |
|
|
|
|
New Jersey TTC inspected by the
American authority on Health and
Safety at Work |
|
Hovione’s Technology Transfer Centre was
inspected, for the first time in October 2005, by the U.S. Department of
Labor – Occupancy Safety & Health Administration (OSHA), the authority
responsible for regulating the Health and Safety issues of US companies. The
three day inspection included a detailed visit to the site as well as
several interviews to employees of various areas and is part of a routine
inspection program carried out by OSHA at all companies operating in the
USA. It occurs without prior notice and the level of detail regarding Health
and Safety at Work can be compared to an FDA inspection. The following
examples illustrate situations noted but since corrected: the existence on
site of a hand-truck without training records (this unit was under
evaluation), the distance of the guard on the grinder machine in the
maintenance workshop being 3/8” off (about 1 cm), additional detail required
on training records, fluorescent lights being placed below a 12 ft (4m)
limit, etc.
At the end of the inspection a Citation and
Notification Penalty was issued which must remain visible to all employees
and visitors until all observations have been solved. The inspector also
determined a penalty amount of US$ 12,500 to be paid and, according to the
law, gave us 15 days to solve problems.
A meeting and respective follow-up was held
within the established time limit at OSHA’s offices in Marlton, New Jersey
with the presence of Dave Hoffman, Michael Humora, António Santos and
Richard Barnett who presented all the corrections carried out
Result: The penalty to be paid was
reduced by 85% and OSHA’s Regional Manager considered the inspection result
as excellent, especially since we were visited by one of the strictest
inspectors!
But this was not all: he recommended
that we join the Voluntary Protection Plan intended for exemplary
installations and, as a result, the TTC’s Board of Directors decided to hand
in their application on February 15th. Joining this plan involves being
audited for a week by 2-3 inspectors. If we are successful in this rigorous
certification process, Hovione will become part of a very restricted group
of industrial companies that practice Health and Safety at Work at the
highest levels of excellence. This is a highly regarded certification in the
USA where Safety and Quality are treated with the same rigour.
|
|
|
FDA inspection |
|
As already reported the Loures plant
was inspected by the FDA in September 2005 and there were 11 items
registered on a Form 483. Following the FDA’s request, the report left
by the inspector was replied to within 30 days and a precise plan was
sent detailing the actions which are being complied with and implemented.
We await official information of our continued approval from the FDA. It
is with a spirit of constant improvement of our procedures and quality
system that we press on, and it is never too much to remember the
lessons learned from Thomas Arista’s inspection.
- All amendments/corrections carried
out to records must be documented.
- All decisions must be based on
concrete facts and data and according to a clear “rationale” duly
documented and registered.
- Every action must be described by a
detailed procedure.
- Any deviation detected must be
recorded directly on work documents and reported to a superior.
- GMP documentation must be short,
clear and accurate both in substance and in form.
- We must know how to communicate our
ideas in a clear and concise manner and be humble when faced with
facts.
|
Hovione in the top ranking
of companies with highest R&D in Portugal |
According to a report from the Observatory of Science and Higher
Education (OCES), Hovione is in seventh place among the 50 largest
companies with R&D in Portugal. On the industrial level, it is the third
largest investor in R&D, after Siemens and the Simoldes Group. The
results of this survey reflect the importance of Hovione’s R&D spending
in Portugal during 2003. Within the Portuguese pharmaceutical industry,
Hovione is the largest investor in R&D and its great commitment to
innovation is marked by its technological capability and scientific
quality. |
|
|
|
Miguel Calado appointed
Chief Financial Officer |
Miguel Calado, has joined Hovione in the capacity of Chief Financial
Officer and as a member of the Executive Committee, with
responsibilities at Group level and his main mission aims to reinforce
our financial performance and to develop our ability to measure
management performance.
With 50 years old, dual national,
Portuguese and US, he obtained his business training in Brazil, working
first for Samarco Mineração, a company of the GE group. He spent 15
years with PepsiCo Inc. where he held a number of senior executive
positions, first in Asia (Hong Kong and Singapore) as Vice-President
Finance for Pepsi-Cola International-Asia Pacific, then as Senior
Vice-President Finance and Chief Financial Officer for Frito-Lay
International in the US. In 1998 Miguel joined Dean Foods as Executive
Vice-President and President for International Operations. He is also a
board member at HNI Corp and has an advisory role at the Universidade
Católica in Lisbon where he occasionally teaches.
|
|
|
|
2006 begins with an analysis
of the year’s challenges |
|
2006 will be another year of much work and great challenges for all of
us at Hovione. January is typically the month when the Group strategies
are defined and approved ready for the cascading process for all areas.
This year, the biggest challenges ahead, drawn from the 7th Short Term
Plan, were discussed and analyzed in two Management Meetings held in a
Lisbon hotel.
“Management Meetings” – already know as MM, the first Management
meeting took place on January 4th with the
objective of presenting and
discussing the Short Term Plan, the Vision Map and the most critical
issues to be covered during 2006 at the Loures site. The new groupwide
Internal Communication Plan to be implemented during the year was also
presented. The day’s work, considered very rewarding by those present,
gave rise to the strategic objectives for the Loures site for 2006.
The second meeting, held on January 20th, involved representatives from
all sites: Macau, Hong Kong, New Jersey and Loures. Group issues
concerning inter-site relations were addressed, intended to incentivate
a better understanding of “the other side”. It was an excellent
opportunity to get to know and work with colleagues from far away and
resulted in a very successful session where inter-site problems were
solved and objectives were set at Group level.
| The “Vision Map”
is a new document for all of Hovione’s employees, which
establishes the company’s Vision as well as its main goals,
priorities and values. Written and approved by the Executive
Committee, the purpose of the Vision Map is to convey an
unequivocal message to all who work for Hovione – there are more
than 600 of us working in three continents – it is vital that, in
our very diverse jobs, we all have a clear notion of our common
purpose and of the direction towards which we must focus our
efforts. |
|
|
|
|
Improving Internal
Communications |
As people, we all know how to communicate easily and instinctively
but within a company setting we seem to forget and no longer know how to
do it.
We started the year with a new Internal
Communication Plan, developed under the scope of Charter 12, with the
commitment and support of Hovione’s top management. The Plan involves
all sites and is composed of 10 specific actions with the objective of
improving:
- Company strategy and management
decisions communciation
- Vertical communication
- Horizontal communication between
areas and sites
| For a Company to
sustain a sound development and good performance, relationships of
mutual respect and trust are essential for people to work together
in harmony towards a common purpose and goal. |
Communication is something that, as
people, we do easily and instinctively every day but the fact is that it
becomes more complex in organizations of a greater dimension. The plan
will help to some extent but the commitment and efforts of all are
essential for its success. Specifically, the 10 actions of the Plan (communicated
in detail internally) will promote communication where it is most
lacking. For example the recently implemented “Vision Map” will
propagate our strategy, values and culture internally in order to
establish a stronger connection between all employees and the business
and its future. The iCLOCK, on the other hand, is a tool
accessible through Sharepoint which centralizes in calendar form, all
relevant company management events and respective documents concerning:
Strategy, Human Resources, Finances, Sales, Internal Logistics, Events,
CEO Communications, Top Management and Line Management communications
(LM comms).
LM comms will, in turn, demand a conscious effort
from management in sharing the information with their staff, a process
which should be done at all levels. This is one of the most important
and comprising actions of the plan.
Also to be noted is the fact that
work is already underway to improve communication channels and
information sharing tools such as Sharepoint. Finally, a
questionnaire to all employees, to be carried out now and in a
year’s time, will evaluate the performance and results of the
implemented measures. |
|
|
|
Hovione launches new website |
Hovione has launched a new version of its website www.hovione.com with a
fresh new look and revised contents. The main objective of the revision
was to up-date its main structure to reflect more accurately our
business and competences for the benefit of our customers and other
interested partners. We have also made every effort to maintain and,
where possible, improve the speed, functionality and the high degree of
information that characterize the Company's website.
More specifically, the website now
includes the following new features:
- Infonet Service – a free
Hovione service for business partners (registration required) to view
pre-selected industry regulatory data.
- Restricted Access Areas –
centralized and directly accessible from the home page: NavStream
application, Protected pages, Infonet service and Registration page.
- Company updates emailing service
- Direct access from the home page for business partners to register
and receive regular Company updates by email.
- What's new area – with
regular updating, what's new at Hovione is highlighted through a
direct links from the home page.
The main menu also includes two new
sections entitled:
Galenic Development, reflecting
Hovione's new capabilities in this area – this includes up-to-date
information on FlowCaps, Formulation, APIs for Inhalation, Particle
Design and Spray Drying.
Areas of Expertise, which have
been updated according to Hovione's latest developments and also
categorized for easier reference. This area includes 5 new expertises:
Technology Transfer, Supply Chain Management, Particle Design, Spray
Drying, APIs for inhalation.
Translations of sections into foreign
languages, namely to French, German and Japanese are being concluded.,
updating the information currently available from our previous website
version. The Portuguese website
www.hovione.pt will undergo a similar revision during the next
months.
We invite you to visit our new website
and welcome your comments and suggestions. |
|
|
|
Hovione at Internacional
Trade Shows |
CPhl-The
Largest World Fair for Chemical and Pharmaceutical Products
With 20,000 visitors from 110 countries, 1500 exhibition stands and 5
pavilions from the Madrid Fair, the show was held from the 1st to the
3rd of November 2005. Hovione participated for the 13th time at CPhl. To
give an idea of the growth of this event, the first edition took place
in 1990 with 250 visitors from 16 countries!
18 people from Hovione were present at
our stand. Three days full of activity and intensive work with the Sales
Group attending more than 60 meetings with customers and the Purchases
Group taking part in 100 meetings with present and future suppliers.
Hovione features regularly in the
event’s daily magazine showing the most relevant participants at the
Show and also had an article published on the Show Daily by Guy Villax
“GMP now Requirement – Finally!”
AAPS
– American Association of Pharmaceutical Scientists
Hovione exhibited for the second time at the AAPS annual meeting. This
fair, held in Nashville, USA, from 6th to 10th of November 2005, is a
meeting of researchers from the pharmaceutical industry and from the
universities that develop new formulations. This meeting attracts around
7,000 people looking for new technologies and suppliers of raw-materials
and services. Hovione’s presence in this show is in line with our
strategy to offer galenic services that complement our main activity in
APIs.. These services are related to particle design engineered with
technologies such as micronization and spray-drying. Promoting these
technologies and our experience in this filed is an element that
distinguishes us from the competition and allows us to gather new
contacts and potential customers. This year around 60 people visited our
stand. |
|
|
|
Intelligence Matrix |
The objective of the Intelligence Matrix,
an internal application developed at Hovione in 2005, is to allow the
selective distribution of public information about the Industry to all
who need it – the Matrix comprises information about current work at
Hovione as well as other topics relevant to our activity thus
contributing to the definition of marketing strategies and competitive
management.
Go to http://matrix.hovione.com,
and select those categories that are most relevant to your work..
Whenever such information is found it will be forwarded to you by email.
Please make the best use of this tool and if you think you have
information that you think should be made available (information on
competition, scientific article, prices, personnel changes) please
contact José Luis Pires,
Webmaster. |
|
|
|
Asian Inspectors visit
Hovione Loures |
On October 13th and November 17th 2005 Hovione Loures was visited by two
groups of 17 inspectors from Asian countries who were attending a
training plan to become official inspectors for the health authorities
of their countries. They came from Indonesia, Malaysia, Singapore,
Vietnam, Korea and the Philippines.
The purpose of their visit to Hovione
was to show how a solid and robust quality system is implemented, which
leads us to believe that Hovione is more than ever known by the national
authorities as a model company where the Quality System is the key to
success. |
|
|
|
Hovione’s New Health, Safety
and Environment Policy |
Following the implementation of the Health, Safety and Environment
Management System and the planned ISO14001 certification, it was decided
to draw an integrated policy for HSE that is in agreement with the
nature, scale and requisites applicable to the Hovione Loures plant.
This policy combines the previous Health and Safety policy and the
Environment policy.
| Health, Safety
and Environment Policy
The protection of people,
facilities and the environment is a strategic imperative for
development and is a constant source of concern for Hovione
FarmaCiencia SA, relying on the following principles:
- We comply with the applicable
legislation and other requirements including the principles of
Responsible Care®;
- We design facilities,
processes and operations in agreement with principles that
assure safety, health and the environment;
- We evaluate and prevent risks
to health and safety and the impact on the environment of all
areas of Company activity;
- We adopt adequate policies for
the management of waste, emissions and natural resources that
prevent pollution and are, whenever possible, integrated and
autonomous;
- We inform and train our
employees and demand that they act responsibly in the defense of
health, safety and the environment using common sense and in
alignment with the business;
- We investigate and implement
corrective measures to prevent the recurrence of all
non-compliant situations;
- We maintain a cordial and
constructive relationship with every stakeholder based on a
spirit of mutual respect and dialogue;
- We improve continuously in
safety, health and the environment, reviewing our performance
and setting targets.
|
|
|
|
|
Internal HSE Auditors Training |
Following the implementation of the new HSE Management System , training
of HSE auditors, coordinated by an external training auditor, was
carried out during the last month of December (according to ISO14001 and
OHSAS18001 standards). After this training/audit our stock of internal
HSE auditors is composed of the following employees: Ana Geraldes,
António Almas, António Gomes, Elisabete Mateus, Filipa Perestrello, João
Alves, João Pina, Jorge Guerreiro, José Saraiva, Luísa Paulo, Miguel
Martins, Paulo Baião, Pedro Duarte, Pedro Furtado e Rafael Antunes. The
observance of internal audits to the whole management system and related
areas is one of the necessary requirements for the environmental
certification according to ISO14001. |
|
|
|
MBA Students visit the Macau
plant |
The Macau plant was visited by a group
of 24 MBA Eller students from the University of Arizona, accompanied by
Prof. Robert Tindall, on 9th December 2005. The objective of this visit,
which occurs annually, is to provide MBA students with a general view of
a factory since Hovione is one of the few high technology manufacturing
plants existing in Macau. As a rule, Hovione Hong Kong organizes the
visit and the “Certificate of Appreciation” issued after the visit shows
the gratitude of the University for our hospitality. |
|
|
|
Filipe Gaspar on the Editorial Board of Pharmaceutical
Technology Europe |
Filipe Gaspar has been invited to
be part of the Editorial Board of Pharmaceutical Technology Europe,
a magazine that is a reference in the European pharmaceutical field. This invitation reinforces the industry’s recognition of Hovione and
its technical capabilities. |
|
|
|
Technology Transfer
– PP03 |
At the end of January another
technology transfer was successfully completed, this time of the
product PP03, from the Research and Development Unit (RD) to the
Manufacturing Unit. This transfer of responsibilities between areas
was symbolically celebrated with a toast by the elements involved in
the project. |
|
|
|
Quality Control
innovates in automatic calculation |
|
Work has been developed, under Charter 13, at the Millennium
software level to enable automatic integration of HPLC and GC
chromatograms which led to the validation of the intermediate
calculation and final results performed by this software. Previously,
both the chromatogram integration and calculation were carried out
manually. For example, in the case of an antibiotic, the integration
procedure, the issuing of LIMS analytical results and its
verification lasted 4 and half hours. With the implementation of
automatic integration and calculation via Millennium, this period is
reduced by half. The next objective will be to introduce this
procedure in the analysis of the contrast media products. |
|
|
|
Hovione receives foreign
visitors daily |
Did you know that Hovione is visited every day of the year by foreign
visitors? Customers, suppliers, consultants and auditors constitute a
permanent flow of visitors, who together with our national visitors,
enrich our experience and knowledge. The internal tools “Who’s visiting/Who’s
travelling” available on the intranet provide a schedule of all business
visits as well as trips made by our staff, including participation at
conferences.
This way it is possible to assess the
number and type of visits received at our installations as well as trips
carried out by Hovione employees.
Besides these tools, there is an easier
way to check if we have foreign visitors: a look at the flags hoisted at
the entrance of the site will show you the nationality of the visitors.
It is our way of welcoming and greeting visitors and of letting the
community know that we have visitors!
|
|
|
 |
Editors: Isabel Pina, Sofia
Villax • With the collaboration of:
António Mendes (NJ); Luisa Paulo (CM); Filipe
Vicente (FA); Cristina Alves (QP); José Luis Pires (CD); Paulo Baião (DGF);
Carla Vozone
(NJ); Ana Chitas (SE); Sofia Lee (HHK) |
-
If you would like to receive
regular news and technology updates from Hovione by e-mail, please
click here
-
If you would like to be removed from
the HOVIONEws mailing list, please
click here.
|
|
|