Welcome to Jiangsu Assure Pharma Biotechnology Co., Ltd.
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Laboratory System and Qualification

  • System

    CMA / CNAS (ISO / IEC17025) Accreditation

    cGMP Compliance Laboratory QA System Independent

  • Equipment

    IQ / OQ / PQ Qualification

    Annual Qualification, Intermediate Check, Calibration Access Management

  • Data

    Meets FDA 21 CFR Part 11 Requirements

    Network and Database Workstations, Audit Trails, Data Remote Backup

    Data Confidentiality Management

  • Personnel Training

    Professional Skills Training

    Compliance Training Confidentiality Training

  • Analysis Method

    Refer to ICH / FDA / ChP / USP / EP / JP / ISO / GB and Other Standard Methods

    Data and reports can be used for new drug applications in China and globally market

Laboratory Qualification

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