Services >  pharmaceutical


Drugs and cosmetics
The rules for the analysis of drugs are uniformly defined in the Pharmacopoeia Europea and may be supplemented by national pharmacopoeia. The EU Directive 2001/83 / EC defines drugs as substances or compositions that are "intended for treating or preventing human or animal diseases" or suitable for influencing physiological functions or to make a medical diagnosis.

 

From developement until the release and even during the production a microbiological examination is advised and can be even mandatory. The absence of pathogens must be ensured, as well as keeping specified limits on microbial level on pharmaceuticals products. Q-Bioanalytic GmbH was audited by "Good manufacturing practice" standard (GMP) for microbiological samples and passed. Through established and validated in-house methods, Q-Bioanalytic GmbH is able to complete analysis on specified microorganisms such as E. coli, P. aeruginosa, S. aureus and Salmonella in less then 24 hours.

 

Parameter recommended for pharmaceutical products:

  • TAMC - total aerobic microbial count
  • TYMC - total yeast / mould count
  • Gallensalze tolerierende, gram-negative Bakterien
  • Escherichia coli
  • Pseudomonas aeruginosa
  • Staphylococcus aureus
  • Salmonella