CDMO Hovione has announced results from a total of 8 inspections at its manufacturing sites in 2017 as part of a new transparency effort. The report covers pre-approval, GMP, and surveillance inspections by regulators from the US, Russia, Japan, and the EU at sites in Portugal, Macau, and Ireland.
Six of the inspections resulted in either no Form 483 or granting of a GMP certificate, the company said. For an FDA pre-approval inspection of the facility in Portugal the outcome included 6 observations and site approval. A GMP inspection of the Macau facility by Japanese regulators resulted in a report of 11 minor observations.
Hovione VP of Quality Joerg Gampfer commented, “Each inspection at Hovione is considered to be of highest importance for the organization and for our customers. We are considering every audit and every inspection as a learning opportunity to continuously improve our Quality Systems and Operative Mechanisms. The number of inspections and their outcome demonstrate our commitment and capacity in the development of new drugs, and ability to manufacture highest quality products for our customers as well as for millions of patients that we proudly serve together. We are especially happy to share that all of the GMP surveillance inspections were concluded successfully with no form 483 observation.”
VP Marketing and Sales Frédéric Kahn added, “We have a culture of quality that puts patient safety first. These inspections are important steps for Hovione and our customers. They shape our behaviors and motivate us to always improve our services to customers. Hovione has all the ingredients for an outstanding partnership going from clinical programs all the way to commercial supply.”
Read the Hovione press release.
