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QA Coordinator: Project Identification No. Name of Product: Dosage Form: R & D Coordinator

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.

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zakir957
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246 views2 pages

QA Coordinator: Project Identification No. Name of Product: Dosage Form: R & D Coordinator

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.

Uploaded by

zakir957
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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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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