Compliance at Hovione, Annual Inspection Review

LOURES, Portugal, March 8, 2018 /PRNewswire/ -- Hovione announced today that in the last year their manufacturing facilities were the object of eight inspections, performed by different Health Authorities. The inspections revealed that all Hovione sites were in compliance, this reflects a solid Quality System and a vibrant Quality Culture.

This is the first press release that reports on the outcomes of inspections in the previous year.  This will now be a regular commitment, it is another feature of our commitment to transparency.

Hovione inspections during 2017

Site

Authority

Date

Type of inspection

Outcome

Portugal

Ministry of Healthcare of the Russian Federation

Jan 2017

PAI for an Intermediate Drug Product

GMP certificate granted

Jul 2017

PAI for an Intermediate Drug Product

GMP certificate granted

FDA, USA

Mar 2017

PAI for an Intermediate Drug Product

Form 483 – 6 observations 
– site approved

Nov 2017

Surveillance inspection

No Form 483

INFARMED,
Portugal, EU

Jul 2017

GMP inspection to a new building

GMP certificate granted

Macau

PMDA, Japan

Dec 2017

GMP inspection

11 minor observations reported

Ireland

Ministry of Healthcare of the Russian Federation

Jul 2017

PAI for an Intermediate Drug Product

GMP certificate granted

FDA, USA

Dec 2017

Surveillance inspection

No Form 483

 

"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," said Joerg Gampfer, Vice President of Quality at Hovione.

"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," added Frédéric Kahn, Vice President Marketing and Sales.



Contact

Isabel Pina, Director of Corporate Communications  
Tel: 0035121 982 9362
Email: ipina@hovione.com   

SOURCE Hovione

 

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Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.