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                                    Nº18  |  February  |  2006
   
  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)

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