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  • 體外診斷試劑運輸穩定性研究方案shipping Study Protocol

    Shipping Study SOP

    1Purpose

    The purpose of this procedure is to provide guidance and identify the requirements on applicable standards for shipping study on all XXX products.

    2Scope

    The scope of this procedure encompasses all shipping stability related activities of XXX products in R&D, QC/QA and Manufacturing Departments of XXX . The shipping stability testing of in vitro diagnostic (IVD) reagents includes Lateral flow products, calibrators, control materials and kits.

    3Reference

    EN13640: 2002 Stability Testing of In Vitro Diagnostic Reagent

    Design Control SOP

    Accelerated Stability Study SOP

    XXX Gold Color Card (for LF)

    XXX’s Final QC Procedure for each product subjected to shipping study

    4Responsibilities

    4.1The Research and Development Department is responsible for conducting shipping study

    including planning and conducting the actual shipping study activities, writing and routing study reports. R&D is also responsible for updating the shipping study file and determining if

    a simulated or real shipping study is needed for a product. Also, The R&D is responsible for

    performing functional testing of simulated shipping study according to corresponding XXX’s Final QC Procedure, and provides the Functional Testing Record.

    4.2Quality Assurance is responsible for ensuring that the shipping study is performed in

    accordance with this procedure. They are also responsible for maintaining the shipping study files.

    4.3Quality Control is responsible for performing functional testing of real shipping study

    according to corresponding XXX’s Final QC Procedure, and provides the Functional Testing Record to R&D department as part of the shipping study report.

    4.4Manufacture Department is responsible for manufacturing products that require shipping

    study.

    5Materials:

    5.1Three batches of XXX Product for shipping study

    5.2Kit Box

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