C&EN, June 5, 2017
Hovione's active pharmaceutical ingredients plant in Macau underwent a pre-approval inspection by FDA; this was triggered by a filing by a US customer. The inspection, carried out by Ms. Karen Moksnes, Compliance Officer at the U.S. FDA Center for Drug Evaluation and Research (CDER) and by Ms. Susan Ting, Chemist at the U.S. FDA Office of Regulatory Affairs (ORA), lasted 3 days, and resulted in a Form 483 with two minor points. Mr. Luis Gomes, General Manager of the plant, said "the inspection was concluded one day early, and by the closing meeting the two points had been satisfactorily addressed".
Hovione plants have been the object of 13 FDA inspections, with 5 at the Macau site since it started to operate in 1986. This inspection reflected the "Risk-Based Management Plan" described in its Pharmaceutical Quality for the 21st Century: The emphasis is on the design and operation of the quality system and on the competence and understanding of the operators and analysts. The thoroughness of the inspection and its ability to make an assessment of the maturity of "GMP mindedness" is far greater. The obvious objective is to be able to determine the plants', and the plant management's, "credibility and reliability" rating that is used in FDA's Risk-Based calculations.
The Macau plant has today a total workforce of 133 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.
Hovione is a world-class company dedicated to the process development and compliant manufacture of APIs and eAPIs for the Pharmaceutical Industry. With a 40-year track record of quality standard and advanced particle design technologies, such as micronization, jet milling and spray drying, Hovione offers APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. With FDA inspected plants in Europe and the Far East and a Technology Transfer Centre in New Jersey, no manufacturing partner is better positioned to support your API development from gram scale to commercialization. Hovione's capabilities include process chemistry, worldwide regulatory affairs, kilo to multi-ton manufacture of complex multi-step chemistry of APIs under FDA and ICH cGMP quality standards. Hovione has process capabilities in the areas of particle design and inhalation drug delivery.