28th May 2012 Content supplied by: vermicon AG
Microbiological Analyses for Pharmaceutical Purposes
vermicon AG located in Munich, specialist in the field of microbiology, has now been certified in accordance with the GMP standard by the government of Upper Bavaria. It is now also an accredited pharmaceutical testing laboratory pursuant to § 67 para. 1 AMG (German Pharmaceuticals Act).By applying the FISH (fluorescence in situ hybridization) technology, which is outlined by chapter 5.1.6 of the European Directorate for the Quality of Medicines & HealthCare, vermicon is able to visualize and analyze microorganisms without any cultivation directly within samples. The technology stands out due to its rapid procedure as well as its high specificity and thus constitutes a high-quality, cost-efficient alternative to conventional microbiology. "We want to share our years of experience across the various industrial sectors as well as the underlying research with the healthcare industry. In consequence we decided to make our analytics accessible to pharmaceutical companies and contract manufacturers" Dr. Jiri Snaidr, CEO of vermicon AG, explains. "Our method absolutely provides additional benefit for this sector." vermicon is subject to supervision by the government of Upper Bavaria including regularly inspections under § 64 AMG (German Pharmaceuticals Act). All analyses results obtained by vermicon may thus be used in the field of drug development and their release.
vermicon was able to establish a coherent quality management system which abides high quality standards with its focus laid on the European GMP guidelines. vermicon's quality management representative supports projects starting with the contractual assignment of pharmaceutical tasks and subsequent method validation to the final issuing of evaluation certificates. Implementing a functioning quality management system according to the GMP standard is not completed upon certification - only constant monitoring and continuous efforts to improve applied systems guarantee customers consistent high quality in their provided services.
Date Published: 28th May 2012