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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.
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.
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.
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 `