Successful FDA Inspection at Hovione’s API Manufacturing Plant in Loures, Portugal

September 29, 2009

LOURES, Portugal, September 29 /PRNewswire/ — Hovione’s API plant in
Loures, Portugal has just successfully passed a pre-approval inspection by

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
, 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

For more information about Hovione, please visit the Hovione site at
http://www.hovione.com or contact Corporate Communications, Isabel Pina,
+351-91-7507-462 or +351-21-982-9362, e-mail: ipina@hovione.com.

SOURCE Hovione FarmaCiencia SA

Source: newswire

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