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Quick facts about
Archimica quality |
| We operate 5 sites under cGMP |
| We have 4 sites that are FDA inspected |
| We have 2 sites that produce
sterile APIs |
| More than a dozen regulatory audits since 2004 |
| Ten inspections by the FDA in the last 5 years |
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A passion for quality
Quality and its impact on the regulatory approvals process is one of the central features of Archimica’s work for the pharmaceutical industry. Based on a long tradition of API manufacture, Archimica’s approach to quality control is based on developing best-in-practice procedures at a single facility and then replicating those practices at each of its facilities around the world.
Quality news
Sandycroft, UK
The Archimica facility at Sandycroft has enjoyed an excellent FDA record with the last inspection in June 2008. More recently, in January 2008 the site was successful in obtaining a new cGMP certificate from the regulatory authority in the UK, the MHRA.
Tonneins, France
In June of 2007, Tonneins, France site including its aseptic filtration facilities was successfully inspected by the FDA.
Springfield, Missouri, USA
In 2010, Springfield, Missouri, USA passed 15 straight years in which no 483 observations had been given to the facility.
Origgio, Italy
In May 2010, Origgio, Italy was successfully audited by the FDA with no 483 observations.
In November 2005, Archimica completed a major investment in finishing facilities typically associated with active pharmaceutical ingredient production immediately prior to final dose preparation. The project has resulted in the very latest facility design, equipment and systems for this phase of commercial-scale manufacturing. This investment provides facilities that are best-in-class for quality in an FDA regulated environment today, and positions Origgio to maintain that best-in-class status for the next 10 years. The primary focus of this investment is to support new API launches.
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