HOT POST

50/recent/ticker-posts

Header Ads Widget

Checklist for New Product

PEOPLE ALSO READ: Audit Checklist for Store Department

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


PEOPLE ALSO READ: Vendor Audit Check List



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

 

 

 



PEOPLE ALSO READ: Internal Audit Checklist for Engineering Department


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


PEOPLE ALSO READ: Audit Checklist for Store Department

Post a Comment

0 Comments

close