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    Roxana Arauco Marin
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    The document provides manufacturing information for metal stents and sets. It describes that a device master record is created for each product and maintained by the Document Control Department. Raw materials are received, inspected, and stored at Cook Ireland. They are then distributed to manufacturing areas according to work orders for product assembly, inspection, packaging, labeling, and sterilization. Suppliers are controlled according to purchasing procedures. An appendix includes a flowchart depicting the manufacturing process from raw materials to finished goods storage.

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    The document provides manufacturing information for metal stents and sets. It describes that a device master record is created for each product and maintained by the Document Control Department. Raw materials are received, inspected, and stored at Cook Ireland. They are then distributed to manufacturing areas according to work orders for product assembly, inspection, packaging, labeling, and sterilization. Suppliers are controlled according to purchasing procedures. An appendix includes a flowchart depicting the manufacturing process from raw materials to finished goods storage.

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    © All Rights Reserved
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    3 views2 pages

    Flujograma

    Uploaded by

    Roxana Arauco Marin
    The document provides manufacturing information for metal stents and sets. It describes that a device master record is created for each product and maintained by the Document Control Department. Raw materials are received, inspected, and stored at Cook Ireland. They are then distributed to manufacturing areas according to work orders for product assembly, inspection, packaging, labeling, and sterilization. Suppliers are controlled according to purchasing procedures. An appendix includes a flowchart depicting the manufacturing process from raw materials to finished goods storage.

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    of 2

    Section 7.

    Manufacturing Information

    Metal Stents/ Sets


    ITF049-MSS

    7.0 Manufacturing Information

    A device master record is created on demand for each product through D00059884
    (QSI1601), Compiling device master records and device history records. Device
    master records are maintained by the Document Control Department / Product
    Lifecycle Management (PLM).

    The basic manufacturing flow from receipt of raw materials through storage for
    distribution is described as follows:

    Raw materials are received and inspected at Cook Ireland. After incoming inspection
    and acceptance, the raw materials are stored in the raw materials storage area.

    Raw materials are distributed to each manufacturing area, as per individual work
    orders for finished product assembly, inspection and packaging and labelling. After
    final inspection, packaging and labelling, non-sterile products proceed directly to
    finished goods store, whereas products destined for sterilisation proceed to Synergy
    Health Ireland Ltd. , a STERIS company. After sterilisation, products return to Cook
    Ireland, where after confirmation of sterilisation, products are transferred to our
    finished goods store.
    Suppliers are controlled and categorised as per D00059409 (QSP0600), Supplier
    Approval and Purchasing.

    Refer Appendix E for Manufacturing flow chart, depicting the process.

    Megha Bhapkar (DV0001519) 11 May 2020 (DV0001519)


    ______________________________ ______________________
    Regulatory Affairs Date

    Page 1 of 1
    Appendix E: Flowchart- Cook Ireland Manufacturing Process
    ITF049-MSS Metal Stents/ Sets

    Flowchart 1 - Cook Ireland Manufacturing Process


    Room Stock \Sub Finished Product
    Assembly Process Flow Process Flow
    e.g. dilators / stents only, FLLAs
    Print Finished
    Product W/O and
    Print Room Boat Labels
    Stock or Sub Assembly
    or Bulk Non-sterile W/O
    Build product Raw Materials

    Print boat labels Barcode


    Verification
    FQC Required

    Build Sub- Yes


    assemblies
    Finished Product QC No

    Barcode Packaging
    Verification

    Boxing Yes Boxing


    Required
    FQC Required?
    No
    Production

    Yes Packaging QC Boxing QC

    No Finished Product QC
    Sterilisation
    Required

    Room Stock or Bulk Non- yes


    sterile or Sub Assembly
    Contract Sterilise

    Batch Release
    Post Sterilisation
    Q.C.and Release

    For Production/
    Yes Foil Pack
    Customer Foil Pack
    Required
    No

    No Foil Pack QC
    Customer
    Boxing
    Required
    Yes Boxing

    No
    Finished Goods Boxing QC
    Ship to Customer
    Stores
    Batch Release
    (including analytical
    Testing) if required

    Page 1 of 1

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