FDA Inspects Hovione’s API Manufacturing Plant in Macau
LOURES,
has just successfully passed a pre-approval inspection by FDA.
The inspection, carried out by Mr.
York
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.
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
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
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
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,
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 more information about Hovione, please visit the Hovione site at
http://www.hovione.com or contact Corporate Communications,
+351-91-7507-462 or +351-21-982-9362, e-mail: ipina@hovione.com.
SOURCE Hovione