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  • Project Identification and Product Development Tracking

    Încărcat de

    zakir957
    108 vizualizări2 pagini
    This document outlines the activities and documents required for a new product development project. It includes 28 items that need to be completed, organized by activity or document, the department responsible, responsible person, target date, and any remarks. Key departments involved include Regulatory Affairs, Quality Assurance, various R&D functions, Production, and Supply Chain Management. The document provides a comprehensive plan to develop, manufacture, analyze, and approve a new product for market.

    Descriere originală:

    Check List for New Batch

    Titlu original

    Check List for New Batch

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    This document outlines the activities and documents required for a new product development project. It includes 28 items that need to be completed, organized by activity or document, the department responsible, responsible person, target date, and any remarks. Key departments involved include Regulatory Affairs, Quality Assurance, various R&D functions, Production, and Supply Chain Management. The document provides a comprehensive plan to develop, manufacture, analyze, and approve a new product for market.

    Drepturi de autor:

    © All Rights Reserved
    Descărcați ca DOC, PDF, TXT sau citiți online pe Scribd
    Indicator pentru conținut neadecvat
    108 vizualizări2 pagini

    Project Identification and Product Development Tracking

    Încărcat de

    zakir957
    This document outlines the activities and documents required for a new product development project. It includes 28 items that need to be completed, organized by activity or document, the department responsible, responsible person, target date, and any remarks. Key departments involved include Regulatory Affairs, Quality Assurance, various R&D functions, Production, and Supply Chain Management. The document provides a comprehensive plan to develop, manufacture, analyze, and approve a new product for market.

    Drepturi de autor:

    © All Rights Reserved
    Descărcați ca DOC, PDF, TXT sau citiți online pe Scribd
    Indicator pentru conținut neadecvat
    din 2

    Project Identification No.

    Name of Product :
    Dosage Form :
    R & D Coordinator:
    QA Coordinator

    S.No Activity / Documents Responsible* Responsible Target Date Remarks


    Department Person
    1 Manufacturing License RA
    Product Developmental F R&D
    2
    Report / Product manual
    3 Change Control approval QA
    4 Batch size approval F R&D/Plant Head
    Batch Manufacturing F R&D
    5 Record/ Material Work
    Order
    Batch Packing Record/ Data F R&D/ PD
    6
    Sheet / Packing Work Order
    Bill of Material for Pilot / F R&D /Prod / SCM
    7
    Exhibit/ Validation batches
    Vendor Qualification QA
    8 Documents with TSE/BSE
    certificate
    DMF access letter from API SCM
    9
    ( If applicable)
    10 Approved Vendor lists QA
    SAP approval for Material, SCM/ MDM/ QA
    11 Manufacturer, Supplier
    (Material Part Number )
    Specification, STP & MSDS F R&D/ QA
    12
    of Raw Material
    Specification, STP & MSDS F R&D/ PD/ QA
    13
    of Packing Material
    In- process / Release / Shelf F R&D/ QA
    14 life Specifications of
    Product & STP
    Lab scale Stability Study F R&D
    15
    Report
    Analytical Method A R&D
    16
    Development Report
    Analytical Method A R&D
    17
    Validation report
    Approval of Tooling/ F R&D/ QA/ Prod/ SCM
    18 Comparison of Tooling &
    Procurement
    Equipment Qualification QA / Prod
    19
    Report
    20 Cleaning Validation Protocol QA/ Prod
    21 Process Validation protocol QA/ Prod
    S.No Activity / Documents Responsible* Responsible Target Date Remarks
    Department Person
    22 Bulk Hold Study Protocol F R&D/ Prod
    Innovator / Equivalent F R&D
    23
    samples (3 batches )
    Transport Validation Study QA
    24
    protocol #
    25 Dossier preparation# RA
    Date for submission at RA
    26
    Destination Countries #
    27 Tentative Approval date # RA
    Validation scheduled, # Prod/ QA/ F R&D
    28
    1st , 2nd , 3rd batches
    `

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