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  • Guidelines for Basic Intravenous Infusion Evaluation in Clinical Use (Trial)

    CNPPA 2020/04/26 13:13:08

    This guideline put forward the items, contents, reference standards, indicators and reference scores for the evaluation of basic intravenous (IV) infusion in clinical use. Establishment of evaluation items of this guideline fully considers the factors affecting the product quality in the production process and those affecting the drug safety and convenience in use of medical institutions. The evaluation items of basic intravenous infusion mainly include four aspects: the quality system of IV production enterprises, the safety of IV products, the compatibility of the drugs and packaging system, the effectiveness and convenience in clinical use.

    This guideline is intended for use by medical institutions in evaluating basic intravenous infusion. Medical institutions may select and adjust evaluation items, contents, indicators and reference scores in this guideline for evaluation.

    The main drafters of this guideline: Hong Jin, Wei Ji, Zhigang Zhao, Tieying Sun and Zhihai Chen.

    This guideline is drafted in accordance with the regulations of GB/T1.1-2009.

    Attachment:Guidelines for Basic Intravenous Infusion Evaluation in Clinical Use (Trial) (T/CNPPA  3003―2018)