FDA Inspects Hovione's API Manufacturing Plan... ( LOURES Portugal June 30 /- Hovion...)

FDA Inspects Hovione's API Manufacturing Plant in Macau

Date:6/30/2009

LOURES, Portugal, June 30 /PRNewswire/ -- 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 the
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FDA Inspects Hovione's API Manufacturing Plan...( LOURES Portugal June 30 /- Hovion...)