Checklist for New Product

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

Sr. No	Activity / Documents	Responsible Department	Responsible Person	Target Date	Remarks
1	Manufacturing License	RA
2	Product Developmental Report / Product manual	F R&D
3	Change Control approval	QA
4	Batch size approval	F R&D/Plant Head
5	Batch Manufacturing Record/ Material Work Order	F R&D
6	Batch Packing Record/ Data Sheet / Packing Work Order	F R&D/ PD
7	Bill of Material for Pilot / Exhibit/ Validation batches	F R&D /Prod / SCM
8	Vendor Qualification Documents with TSE/BSE certificate	QA
9	DMF access letter from  API  ( If applicable)	SCM

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10	Approved Vendor lists	QA
11	SAP approval for Material, Manufacturer, Supplier  (Material Part Number)	SCM/ MDM/ QA
12	Specification, STP & MSDS of Raw Material	F R&D/ QA
13	Specification, STP & MSDS of Packing Material	F R&D/ PD/ QA
14	In-process / Release / Shelf-life Specifications of Product & STP	F R&D/ QA
15	Lab Scale Stability Study Report	F R&D
16	Analytical Method Development Report	A R&D
17	Analytical Method Validation report	A R&D
18	Approval of Tooling/ Comparison of Tooling & Procurement	F R&D/ QA/ Prod/ SCM
19	Equipment Qualification Report	QA / Prod

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20	Cleaning Validation Protocol	QA/ Prod
21	Process Validation protocol	QA/ Prod
22	Bulk Hold Study Protocol	F R&D/ Prod
23	Innovator / Equivalent samples (3 batches)	F R&D
24	Transport Validation Study Protocol #	QA
25	Dossier preparation#	RA
26	Date for submission at Destination Countries #	RA
27	Tentative Approval date #	RA
28	Validation scheduled, # 1st, 2nd, 3rd batches	Prod/ QA/ F R&D

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