Hovione’s API Manufacturing Plant Passes FDA Inspection

Hovione’s API manufacturing plant in Loures, Portugal has successfully passed a pre-approval inspection by FDA.

The inspection lasted 5 days starting on 21st September and concluded on the 25th, covering 5 ANDAs and 1 NDA. No Form 483 was issued.

The company said that 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 the inspection was to evaluate how the ‘guidelines and internal procedures’ are followed in day-to-day plant operations. Special emphasis was given to: root cause determination; preventive and corrective actions implementation and follow-up; impact analysis of the changes and 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 demanding markets such as North America, EU, Japan and Australia.

Luisa Paulo, compliance director of Hovione 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.”