KEYBIO - Microbiological Risk Management

RECOGNITION AND QUALITY ASSURANCE

ONGOING QUALITY CONTROL

The laboratory monitors compliance with the following standards:

  • Norm NF EN ISO / CEI 17025.
    General requirements on the competency of calibration and testing laboratories.
  • Good Manufacturing Practices (France):
    ANSM
    EUDRALEX.
  • Good Manufacturing Practices.
    21 CFR Parts 210 and 211.

The laboratory COFRAC accredited in the following areas:

  • Evaluation of antiseptic and disinfectant efficacy.
  • Microbiological tests of pharmaceutical products, cosmetics, and medical devices.

Information on accreditation is available at www.cofrac.fr.

The Laboratory is FDA approved under no. 3006486533.