Loures, Portugal, June 26th, 2009 – Hovione's API plant in Macau has just successfully passed a pre-approval inspection by FDA.
The inspection, carried out by Mr. Michael Charles, investigator of New York District office in Buffalo and Mr. ChunChang Fang, Chemist from California District initially planned to take 4 days lasted 2.5 days, starting on 22nd June and concluded on the 24th. A Form 483 with five points was issued. At the closing meeting the inspectors informed that they were happy with what they have seen and congratulated our GMP system and the knowledgeable of the team members.
Mr. Jorge Pastilha, General Manager of the plant, said "The inspection was focused on the execution side rather than the documentation system. Inspectors wanted to know “how we did in specific situations” rather than “how we should do in hypothetical situations” . I am glad that we continue to do well in compliance issues."
Hovione plants have been the object of 16 FDA inspections, with 6 at the Macau site since it started to operate in 1986. This inspection reflected that FDA is looking in far greater detail to aspects like "Quality by Design” and “Supply Chain Management”. The thoroughness of the inspection and its ability to make an assessment of the maturity of "GMP mindedness" is far greater. The obvious objective of this inspection was to evaluate how the “guidelines and internal procedures” are followed on the day-to-day activity by operators and analysts. Special emphasis was given to: 1) preventive and corrective actions implementation and follow-up; 2) water systems operation. The way inspectors look to the softened water system is probably a good example of the new “FDA Approach”. They look to basic aspects like the Design, Operational and Performance Qualification and to the last years Annual Report and concluded that the system has a good performance. But on top of this they expect permanent monitoring of several operational parameters of the system, Municipal Water quality and performance of the Municipal Water systems in order to assure reliability. The Macau plant has today a total workforce of 120 professionals and produces both Hovione catalogue generic products and commercial APIs manufactured under exclusivity and has been increasingly used by Hovione customers to produce on an exclusive basis clinical trial quantities of compounds for Phase I and II testing. The facility is responsible for one third of Hovione’s total production, and exports to the most demanding markets such as the USA, EU, and Australia.
Hovione is an international company with 50 years’ experience in Active Pharmaceutical Ingredient development and compliant manufacture. With four FDA inspected sites in the US, China, Ireland and Portugal the company focuses on serving the most demanding customers in the most regulated markets. The company also offers integrated API, particle design and formulation development and manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.
For further information about Hovione, please visit the Hovione site atwww.hovione.com or contact Corporate Communications (Isabel Pina, +351 91 7507 462 or + 351 21 982 9362, e-mail: firstname.lastname@example.org)