Quality Management

BioChem’s Quality Management (QM) and Quality Assurance (QA) is based on the extensive experience of our motivated staff , and our desire to continuously improve our procedures. The implementation of current pharmacopoeia specifi cations, relevant regulations and guidelines, and the safe handling of your products and data are a given for us.
The analyses conducted by the company BioChem GmbH within the meaning of § 14 para 4 no. 3 of the German Medicines Act (Arzneimittel Gesetzes, AMG) are registered with the responsible supervisory authority in accordance with § 67 para 1 AMG. Pursuant to § 64 para 1 AMG, BioChem GmbH is subject to regular monitoring for GMP and GLP compliance by the Control Centre for Drug Monitoring, Baden-Württemberg, and by the Chemicals Act or Directive 2004 / 9 / EG by the State Offi ce for Environment, Measurements and Environmental Protection of Baden-Württemberg.

In addition, BioChem GmbH is registered under the Facility Establishment Identifi er (FEI) 3004058183 with the U.S. Food and Drug Administration (FDA) and has received unrestricted authorization as an independent, internationally operating contract laboratory in two pre-approval inspections  and one comprehensive GMP-system inspection (2009, 2013 and 2016).

BioChem GmbH 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 Wirkstoff herstellungsverordnung, AMWHV), and 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 (MPG).

Regular customer-based audits (> 30 per year) ensure the maintenance of the high GMP and GLP standards that apply to the pharmaceutical environment.