Hovione Announces Successful Inspection
Hovione’s plant in Loures, Portugal, has successfully passed a GMP and Postmarket Approval inspection by FDA. The inspection, carried out by Mrs. Yumi Hiramine, Inspector from the CDER, lasted 5 days as initially planned, starting on September 23 and concluded on the September 27. No Form 483 was issued. At the closing meeting, the inspector informed that she was satisfied with what she had seen and complimented Hovione on its GMP System, inspection organization, and the knowledge of its team members.
“We are pleased to have another successful FDA inspection at our Loures plant completed,” said Guy Villax, Hovione’s CEO. “Doing well in the eyes of an FDA inspector is always a motive of satisfaction and a good reason to congratulate one’s team – well done; but with 65 client audits and inspections per year, our sites are always inspection-ready.”
Hovione’s five plants were the object of 12 inspections in the past 18 months. These inspections were performed by some of the world’s major Health Authorities:
• Five by the US FDA in Portugal, Ireland, Macau, and New Jersey; four of them with no Form 483 issued.
• Three by the Portuguese Health Authority (INFARMED) in Portugal, Macau, and China, which led to GMP certificates granted to each of the sites.
• One by the Irish Medicines Board (IMB) in our Cork plant, which ended with the issuance of GMP certificates.
• One by the Korean FDA in the Portuguese plant.
• Two by the CFDA in China.
“The main objective of theses inspections was to evaluate how the guidelines and internal procedures are followed in day-to-day plant operations,” explained Luisa Paulo, Hovione’s Compliance Director. “Special emphasis was given to how the company records and manages OOS, deviations, change control, batch production records, complaints, validation, and product quality reviews. The inspectors were always pleased to see consistency between daily practice and the quality system.”
Hovione is a global company with over 50 years of experience in API and Drug Product Intermediate 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 regulated markets. For more information, visit www.hovione.com or contact Marketing & Communication, Isabel Pina, + 351 21 982 9362, e-mail: ipina@hovione.com.
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