Loures, Portugal, September 29th, 2009 – Hovione's API plant in Loures, Portugal has just successfully passed a pre-approval inspection by FDA.
The inspection, carried out by Mr. Mark Parmon, Inspector of Cincinnati District lasted 5 days as initially planned, starting on 21st September and concluded on the 25th, covering 5 ANDAs and 1 NDA. No Form 483 was issued. At the closing meeting the inspector informed that he was happy with what he had seen and congratulated our GMP System and the knowledge of team members.
Luisa Paulo, Hovione's Compliance Director, said "The inspection focused on the documentation system, especially on how we record and manage OOS, deviations, change control, batch production records and analytical procedures. The Inspector focused on looking for deviations in consistency of the application of procedures”. Hovione plants have been the object of 17 FDA inspections, with 10 at the Loures site since 1982. The thoroughness of inspections and the ability to make an assessment of the maturity of GMP system is far greater than before. The main objective of this inspection was to evaluate how the “guidelines and internal procedures” are followed in day-to-day plant operations. Special emphasis was given to: 1) root cause determination; 2) preventive and corrective actions implementation and follow-up; 3) impact analysis of the changes and 4) production and analytical operation. The Loures plant has a total workforce of about 500 professionals and produces both generic products, as well as APIs and bulk formulated products manufactured under exclusivity for both clinical trials and for commercial sale. The facility exports to the most demanding markets such as North America, EU, Japan and Australia. About Hovione. 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 the most demanding customers in the most highly 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.