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Checklist of Technology Transfer for Sending Unit

PEOPLE ALSO READ: SOP for Transfer of Analytical Procedure

Project Identification No.

 

Name of Product:

 

Technology Sending Coordinator:

 

Technology Receiving Coordinator (Proposed site)

 



Sr.

Activity / Documents *

Responsible # person

Probable Target date

Sent on

Sent by

1

Product Developmental report

Coordinator

 

 

 

2

Master Manufacturing Record / Batch manufacturing record (Executed)

Coordinator

 

 

 

3

Master Packing Record / Batch packing record (Executed).

Coordinator

 

 

 

4

Tooling Specification

Coordinator

 

 

 

5

Process Validation Protocol & Report

Coordinator

 

 

 

6

Product Cleaning Method – Protocol & report 

Coordinator

 

 

 

7

Specification, STP & MSDS of Active Material(s)

Coordinator

 

 

 

8

Specification, STP & MSDS of Inactive Material(s)

Coordinator

 

 

 

9

Specification, STP & MSDS of Packaging Material(s)

Coordinator

 

 

 



PEOPLE ALSO READ: Validation Master Plan

10

Specification, STP of In-process product(s)

Coordinator

11

Specification, STP & MSDS of Finished product (s)

Coordinator

 

 

 

12

Analytical method validation Protocol & Reports (Finished product) (as applicable)

Coordinator

 

 

 

Assay,

Related substance,

Content Uniformity,

Dissolution profile,

OVI, Residual Solvents

Stability indicating Method. 

13

Analytical method validation Protocol & Reports/ Method transfer protocol of Critical API for (as applicable)

Coordinator

Assay,

Related substance,

OVI, Residual Solvents

14

Trend data for last 10 batches of

Coordinator

API bulk density 

API Particle size.

API Solubility profile.

Excipient’s bulk density 

Excipient’s Particle size.

Finished product trend analysis data





15

Finished Product Samples (3 batches)

Coordinator

 

 

 

16

Product Stability Data

Coordinator

 

 

 

17

Annual Product Review

Coordinator

 

 

 

18

Approved Vendor List

Coordinator

 

 

 

19

Audit Report of vendors (Manufacturer)

Coordinator

 

 

 

20

Product History (Critical product problems)

Coordinator

 

 

 

21

Complaint History and Investigation report

Coordinator

 

 

 

22

Change control / History of product.

Coordinator

 

 

 

23

Technical Agreement

Coordinator

24

Access letters / Marketing authorization

Coordinator

25

Dossiers transfer letters.

Coordinator

26

Country’s FDA approval letter

Coordinator

 

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