CARBOGEN AMCIS Announces Successful FDA Audit
Published: Feb 13, 2012
The cGMP (current Good Manufacturing Practices) Audit for a number of commercial products and also a Pre-Approval Inspection (PAI) for another programme was completed over four days in September 2011. The audit involved an analysis of all systems, procedures and processes related to the development, validation and manufacture of APIs and highly-potent APIs at the Bubendorf site. The inspection was concluded with no Form 483 observations or major/critical findings thus confirming that no concerns were discovered during the inspection.
"The positive conclusion to this latest FDA audit in Bubendorf fulfils our commitment to customers and to the highest standard of quality they expect from us,” commented Mark Griffiths, CEO of CARBOGEN AMCIS. “The fact that we have successfully completed our latest FDA audit speaks to the consistency of quality we offer our customers and continues our long track record of successful regulatory audits. As we move forward, we will continue to pursue opportunities to improve the quality of our products and the safety of our manufacturing process.”
The Bubendorf facility manufactures products according to cGMP standards and is routinely inspected by SwissMedic, the FDA and external customers. The facility underwent successful FDA inspections in 2002 and 2008, yielding no FDA 483 observations.
Currently, the Bubendorf site supports 160 employees who focus on process optimization and supply of late-phase and commercial API and highly potent API supplies; the site includes:
- A 3,000m2 manufacturing facility
- A 2,400m2 laboratory facility
- A 8,500m2 science building
- Twenty-seven general purpose reactors from 100 L up to 2,500 L (stainless steel, hastelloy and glass-lined)
- Fully-equipped synthesis labs, including dedicated containment labs for Product Research & Development (PR&D) and analytics for category III & IV compounds
- State-of-the-art high-potency API development and manufacturing unit for the manufacture of category III & IV compounds
CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Pharmaceuticals and Chemicals Ltd., Ahmedabad, India.
Dishman Group (www.dishmangroup.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe, China and India.
Source: CARBOGEN AMCIS AG, Bubendorf, Switzerland
540 Maryville Centre Drive, Suite 100
St. Louis, Missouri 63141
Web site: www.standingpr.com