Quality Policy
BioGenes is certified according to ISO 9001 since 1999.
More than that, the works performed in our labs, especially for industrial customers comply with GMP and GLP standards. The accreditation for GMP compliant test releases will be completed in the beginning of 2009.
Our quality system employs the following principles:
- Animals and materials from certified suppliers
- Quality according to US standards
- Batch control system
- Cell line history and cell banking
- Assay validation according to the ICH guidelines
- Validated analytical procedures
- Development or production file
- Documentation according to the regulatory guidelines
- Well-experienced and regularly trained personnel
- Routinely internal audits and audits by customers
The animal keeping and corresponding works are performed according to the following animal welfare regulations:
- German guidelines according to § 8a Animal Welfare Act of 18. May 2006 (BGBI.I, p. 1206)
- European Union guidelines 86/609/EWG of 24.11.1986 and according to the European Agreement of 18.3.1996 for protection of animal trials and other for scientific purposes used vertebrates of 11.12.1990 (BGBI. II S. 1486)
- NIH/OLAW Animal Welfare Assurance #A5755-01
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