Navigation Links
FDA Inspects Hovione's API Manufacturing Plant in Macau

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 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 Macau plant has today a total workforce of 120 professionals and 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 USA, EU, 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 serving the most demanding customers in the 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 or contact Corporate Communications, Isabel Pina, +351-91-7507-462 or +351-21-982-9362, e-mail:

SOURCE Hovione
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. SAFC Expands Hi-Potency API Manufacturing and Introduces Solid-Form Testing at Its Madison Facility
2. Middle East Pharma Manufacturing/Biotech is Ready to Boom
3. SAFC Expands European Commercial Manufacturing and Storage Capacities With $10 Million Investment
4. Hyaluron Contract Manufacturing Named a 2007 Economic Impact Award Finalist
5. Alliance for Medical Devices, Instrumentation and Diagnostics formed between Fraunhofer Center for Manufacturing Innovation and Boston University
6. Serica Technologies Expands Facilities in Massachusetts, Combines State-Of-The-Art Textile Engineering and Biomedical Manufacturing
7. Parexel Consulting Strengthens Good Manufacturing Practice Capabilities in Europe
8. Genzyme Begins Major Expansion of Boston Manufacturing Facility
9. SAFC Supports Potent API Conjugate Manufacturing With New St. Louis Production Suite
10. PacificGMP Announces Agreement with BD Biosciences for Cell Banking and cGMP Antibody Manufacturing
11. Thermo Fisher Scientific to Expand Manufacturing Operation for Single-Use Bioprocessing Containers
Post Your Comments:
(Date:6/23/2016)... June 23, 2016  The Prostate Cancer Foundation (PCF) is pleased ... and faster cures for prostate cancer. Members of the Class of 2016 were ... Read More About the Class of 2016 PCF Young ... ... ...
(Date:6/23/2016)... OTTAWA, ON (PRWEB) , ... June 23, 2016 , ... ... former DNA Technical Leader at the Arkansas State Crime Laboratory, has joined STACS DNA ... joining the STACS DNA team,” said Jocelyn Tremblay, President and COO of STACS DNA. ...
(Date:6/23/2016)... 2016 Andrew D ... Published recently in ... from touchONCOLOGY, Andrew D Zelenetz , discusses ... care is placing an increasing burden on healthcare ... therapies. With the patents on many biologics expiring, ...
(Date:6/23/2016)... ... June 23, 2016 , ... Velocity Products, a division of ... and optimized exclusively for Okuma CNC machining centers at The International Manufacturing Technology ... among several companies with expertise in toolholding, cutting tools, machining dynamics and distribution, ...
Breaking Biology Technology:
(Date:5/20/2016)... 20, 2016  VoiceIt is excited to announce ... By working together, VoiceIt and VoicePass ... and VoicePass take slightly different approaches to voice ... security and usability. ... new partnership. "This marketing and technology ...
(Date:4/28/2016)... , April 28, 2016 Infosys ... (NYSE: INFY ), and Samsung SDS, a global ... that will provide end customers with a more secure, fast ...      (Logo: ) , ... but it also plays a fundamental part in enabling and ...
(Date:4/15/2016)...  A new partnership announced today will help ... in a fraction of the time it takes ... life insurance policies to consumers without requiring inconvenient ... Diagnostics, rapid testing (A1C, Cotinine and HIV) and ... weight, pulse, BMI, and activity data) available at ...
Breaking Biology News(10 mins):