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  • Design and Manufacturing Manufacturing Information: Cortisol G2 CS Elecsys: e 401/601/6002 (REF 06687750 190)

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    Amraa Baasankhuu
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    The document provides manufacturing information for Cortisol G2 CS Elecsys reagents. Roche Diagnostics GmbH in Mannheim, Germany is the legal manufacturer. Their facilities are certified under a quality management system according to ISO 13485. An overview of the general manufacturing process is given in an attached flowchart, which shows that components are prepared into a matrix, substances are added, in-process controls are conducted, primary packing through filling is done, secondary packing follows, and QC testing and release occurs.

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    Roche

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    Cortisol_CS_DM-Manuf

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    The document provides manufacturing information for Cortisol G2 CS Elecsys reagents. Roche Diagnostics GmbH in Mannheim, Germany is the legal manufacturer. Their facilities are certified under a quality management system according to ISO 13485. An overview of the general manufacturing process is given in an attached flowchart, which shows that components are prepared into a matrix, substances are added, in-process controls are conducted, primary packing through filling is done, secondary packing follows, and QC testing and release occurs.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    9 views3 pages

    Design and Manufacturing Manufacturing Information: Cortisol G2 CS Elecsys: e 401/601/6002 (REF 06687750 190)

    Uploaded by

    Amraa Baasankhuu
    The document provides manufacturing information for Cortisol G2 CS Elecsys reagents. Roche Diagnostics GmbH in Mannheim, Germany is the legal manufacturer. Their facilities are certified under a quality management system according to ISO 13485. An overview of the general manufacturing process is given in an attached flowchart, which shows that components are prepared into a matrix, substances are added, in-process controls are conducted, primary packing through filling is done, secondary packing follows, and QC testing and release occurs.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 3

    �-

    Design and Manufacturing


    Manufacturing Information

    Cortisol G2 CS Elecsys: e 401/601/6002


    (REF 06687750 190)

    13.Mar.2019 V. Bauer
    Global Regulatory Affairs

    CONFIDENTIAL AND PROPRIETARY


    DM-Manuf
    Page 1 of 3
    1. Manufacturer Information

    Legal Manufacturer:

    The Cortisol CS reagents are manufactured by Roche Diagnostics GmbH (RDG).

    The address is as follows:

    Roche Diagnostics GmbH


    Sandhofer Strasse 116
    D-68305 Mannheim
    Germany

    2. Quality Management System

    The above mentioned Roche manufacturing facilities are certified under a Quality
    Management System according to ISO 13485.

    3. Manufacturing

    A general overview of the manufacturing process is provided in the attached


    manufacturing flowchart.

    CONFIDENTIAL AND PROPRIETARY


    DM-Manuf
    Page 2 of 3
    Manufacturing Flowchart
    For Auxiliaries

    Components

    Prepare matrix

    Add substances

    In process Control

    Primary packing:
    Filling

    Secondary packing

    QC test and release

    CONFIDENTIAL AND PROPRIETARY


    DM-Manuf
    Page 3 of 3

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