Press Room

Press Release / Nov 11, 2004

FDA inspects Hovione's API manufacturing plant in Macau

Hovione's active pharmaceutical ingredients plant in Macau underwent a pre-approval inspection by FDA

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.

 

About Hovione
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.

Also in the Press Room

See All

Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at gmp-journal.com  

Article

Continuous Tableting and the Road to Global Adoption

Mar 04, 2024