FDA Laboratory Receives Accreditation

FDA has announced that the American Association for Laboratory Accreditation has accredited the Laboratory Quality System programme in the Center for Laboratory Quality System.

FDA has announced that the American Association for Laboratory Accreditation has accredited the Laboratory Quality System programme in the Center for Laboratory Quality System (CBER) under ISO/IEC 17025 in the fields of biological and chemical testing.

The ISO/IEC 17025 is a standard developed by the International Standards Organization (ISO) and the International Electrotechnical Commission (IEC) to merge requirements for technical competence in testing and calibration laboratories with requirements for quality systems.

CBER received accreditation for six methods to test influenza vaccines, including those for sterility and potency, and seven methods for evaluating blood donor screening kits that detect the presence of HIV, HBV, HCV, HTLV-I/II, Trypanosoma cruzi, and West Nile virus. These laboratory activities have a direct impact on regulatory decisions. The Laboratory Quality System program supports the development and evaluation of national reference materials and s