BioChem’s Quality Management (QM) and Quality Assurance (QA) are based on the extensive experience of our motivated staff and our desire to continuously improve our processes for compliance with GMP and GLP requirements. The implementation of current pharmacopoeia specifications, relevant regulations and guidelines, as well as the safe handling of your products and data are a matter of course for us.
The analyses conducted by BioChem within the meaning of § 14 para 4 no. 3 of German Medicines Act (Arzneimittelgesetz, AMG) are registered with the responsible supervisory authority in accordance with § 67 para 1 AMG. Pursuant to § 64 para 1 AMG, BioChem is subject to regular monitoring for GMP and GLP compliance by the appropriate German authorities Control Centre for Drug Monitoring (Leitstelle Arzneimittelüberwachung Baden-Württemberg), and by the Chemicals Act or Directive 2004 / 9 / EG by the State Office for Environment, Measurements and Environmental Protection of Baden-Württemberg.
In addition, BioChem is registered under the Facility Establishment Identifier (FEI) 3004058183 with the U.S. Food and Drug Administration (FDA) and has received authorization as an independent, internationally operating contract laboratory in four successful inspections, most recently in November 2017.
BioChem performs contract work according to the current state of science and technology and complies with recognized regulations and relevant statutory provisions, in particular in accordance with §14 and §23 of the German Ordinance on the Manufacture of Medicinal Products and Active Ingredients (Arzneimittel- und Wirkstoffherstellungsverordnung, AMWHV) as well as in accordance with the GMP principles of the “EU GMP guidelines of good manufacturing practice for medicinal products and substances”, “the U.S. Code of Federal Regulations” (21 CFR Part 210/211) and the Medical Devices Act (Medizinproduktegesetz, MPG).
Regular customer-based audits (approx. 30-40 per year) ensure the maintenance of the high GMP and GLP standards that apply to the pharmaceutical environment.
In addition, BioChem has the authorisation for
– handling of narcotics according to §3 BtmG
– handling of narcotic precursor according to GÜG and (EG) 273/2004 Art. 3 Abs. 2 of category 1 substances
– operation of genetic engineering facility according to GenTG and GenTAufzV as well as GenTSV of security level 1 and 2 according GenTSV (biosafety level 2 GMOs on a project-by-project basis only)
Furthermore, we have notified the competent authorities about:
– handling of pathogenic organisms according to §§ 44 IfsG
– handling of epizootic disease germs according to TierSeuchErV