Press Room

Article / Oct 11, 2007

Speech by Guy Villax at the VPP Star Presentation

East Windsor, New Jersey, 11 October 2007

Speech by Guy Villax on the occasion of the presentation of VPP Star plaque and flag

Mr. Ambassador [Mr. Joao Salgueiro, Ambassador of the Republic of Portugal to the UN]
Mr. Roskoski, [Mr. Gary Roskoski, Director- Marlton Area Office. OSHA] 
Mayor Mironov, [Ms. Janice Mironov, Mayor of the Township of East Windsor] 
Mr. Consul General [Mr. Francisco Azevedo, Consul General of Portugal in Newark]
Ladies and Gentlemen,
Dear Friends

I am very glad to be here with you.

I would like to thank the kind words from Mr. Gary Roskoski, Director and Mr. Martin Davies both of OSHA, from Mayor Mironov.

This is an important event for Hovione's Technology Transfer Center – we celebrate OSHA’s acceptance of our application to the VPP Star program.

This acknowledgement of an impeccable HSE record is something that I see as a reflection of the TTC’s standards, of the quality of the management of this site, and in a way this marks the coming of age of the TTC. Indeed this site is only 5 years old – and this is the first time that we have the chance to stop, invite our guests and friends and take a moment to look back. It’s not been easy, but we’ve clearly moved to the next step.

We have established the TTC as a member of an elite group – in the words of Edwin J. Foulke, Assistant Secretary of Labour – not just in HSE terms, but as a service provider of sophisticated R&D services to the pharma industry.

This is the correct moment to say a few words of thanks.

First to the East Windsor Township, its Mayor and Council – because they helped us decide to locate here, they welcomed us and told us “we’ll be as fast as you want provided you do it by the book!”.

Then to CUH2A, our architects that turned a dream, Dave, Bill and I had into reality – or at least into a blueprint – many sushi lunches at figuring out how to make it the best.

Turner and to Dion Hall of Eng Tech – for the hardware.

Millennium BCP bank – supported us all the way, and together with BES, BPI and CGD financed this investment.

The Consulate in Newark for endless stampings of endless papers.

The universities – Rider, Rutgers and Princeton – that lend us a hand only too often, train our young people so they will lead us in the future.

The Twin Rivers association – our neighbours… to whom we have tried very hard to be the opposite of a nuisance.

Certainly our customers – because at the end of the day they are the reason why we exist and succeed – I will pick a few names – Neurocrine Biosciences – because they gave us our first business here; and CVT and Astellas because they bet on us for an important new product.

I’d like to also thank all the Hovione people for their efforts and commitment in turning what back in 1999 and 2000 was but a dream – into a tangible reality that clients and competitors talk about, and journalists write about! Journalists have played an important role in our success - this is something we appreciate very much.

All Hovione sites perform over and above the regulations, and all get awards and commendations – they work hard to be a welcome part of their communities; they are often picked as an example to follow. So when I saw the letter from OSHA in Washington I was particularly pleased, because it came as a surprise – I did not even know the TTC had made the application – and it shows that whether they be in China or in America – Hovione people have the same culture, and look to meet the toughest challenges, to meet the highest standards – not because it is mandatory, but because this is just the way we work.

To achieve this means great team spirit, because Safety is everyone’s job – so cohesion and alignment are part of the whole process. This occasion is also a happy one because it marks an achievement, Diane and I are here, to share it with you – and to tell you how pleased we are to see after 50 years of hard work how we are able to get recognition for a job well done everywhere we go – and how this is the result of people that come from nearby, and from Macau, and from Portugal.

Going forward we have a great challenge – to continue to meet the standard. We all want to retain the VPP Star status – but to keep it requires effort and commitment – one day of lost work will cause us to loose the status… so we need to work hard because from where OSHA has put us, we can only go down… so I count on you.

Lastly I would like to give my congratulations to Dave that has led this project from its beginning and who should feel that all this is the achievement of a team he led, coached, pushed forward and got amazing results from. Congratulations to all of you for a great job well done – congratulations also to everyone else that worked here at the TTC, and may not be here to hear these words. Thank you – well done.

Guy Villax 
Chief Executive 
East Windsor, 11th October 2007

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Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at gmp-journal.com  

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