Quality Assurance

Quality is the basis of the daily work at BioChem Labor für biologische und chemische Analytik GmbH. Our quality is based on the many years of experience of our motivated staff and the will for continuous improvement of our processes while complying with all specifications in the GMP and GLP environment.

Since 2022, in addition to the GMP certificate, BioChem also holds the manufacturer’s authorisation for

• human medicinal products and investigational medicinal products acc. to § 13 AMG as well as
• veterinary medicinal products acc. to § 28 TAMG and (EU) 2019/6.

The manufacturer’s authorisation refers to the microbiological, chemical/physical and biological quality control for medicinal products, raw and starting materials, active pharmaceutical ingredients and packaging materials.

Here you can download our certificates and authorisations.

The tests carried out by BioChem within the meaning of

• § 14 Para. 4 No. 3 of the German Medicines Act (AMG) are

have been reported to the competent supervisory authorities acc. to § 67 Para. 1 AMG.

In addition, in order to maintain GMP and GLP compliance, we are subject to regular monitoring in acc. to

• § 64 Para. 1 of the German Drug Law (AMG) by the authority for the supervision of medicines Baden-Württemberg and
• Chemicals Act/Directive 2004/9/EC by the Landesanstalt für Umwelt, Messungen und Naturschutz Baden-Württemberg (LUBW).

BioChem has been registered with the U.S. Food and Drug Administration (FDA) for many years under Facility Establishment Identifier (FEI) 3004058183, was successfully inspected repeatedly and is recognised as an independent, internationally accepted contract laboratory.

When carrying out contract analysis, BioChem works in particular in acc. to § 14 and § 23 of the AMWHV, to the GMP principles and in acc. to

• “EC Guide to Good Manufacturing Practice for Medicinal Products and Active Pharmaceutical Ingredients”,
• “U.S. Code of Federal Regulation” (21 CFR Part 210/211) and
• Medical Devices Act (MPG)

BioChem also has the following authorisations and notified defined activities to the competent authorities:

• handling of narcotics acc. to § 3 Narcotics Act (BtMG)
• handling of narcotic precursors acc. to GÜG and (EG) 273/2004 Art. 3 Para. 2 of category 1 substances
• operation of a genetic engineering facility acc. to GenTG (Genetic Engineering Act) and GenTAufzV (Genetic Engineering Recording Ordinance) as well as GenTSV (Genetic Engineering Safety Ordinance) of safety level 1 and 2 acc. to GenTG (S2: project bound, according to agreement)
• handling of pathogenic organisms acc. to §§ 44 IfSG (Infection Protection Act)
• handling of epizootic disease germs acc. to TierSeuchErV (Ordinance on Animal Pathogens)

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