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Technology Transfer Checklist for Sending Plant

Project Identification No.

Name of Product:

Technology Sending Coordinator:

Technology Receiving Coordinator

(Proposed site)

Sr Activity / Documents * Responsible # Probable Target Sent Sent

. person date on by

1 Product Developmental report Coordinator      

2 Master Manufacturing Coordinator

Record / Batch manufacturing
record (Executed)      

3 Master Packing Record / Batch Coordinator

packing record (Executed).      

4 Tooling Specification Coordinator      

5 Process Validation Protocol & Coordinator

Report      

6 Product Cleaning Method – Coordinator

Protocol & report      

7 Specification, STP & MSDS of Coordinator

Active Material(s)      

8 Specification, STP & MSDS of Coordinator

Inactive Material(s)      

9 Specification, STP & MSDS of Coordinator

Packaging Material(s)      

10 Specification, STP of In- Coordinator

process product(s)

11 Specification, STP & MSDS of Coordinator

Finished product (s)      

12 Analytical method validation Coordinator

Protocol & Reports (Finished
product) (as applicable)      
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Technology Transfer Checklist for Sending Plant

Sr Activity / Documents * Responsible # Probable Target Sent Sent

. person date on by

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 Coordinator

batches)      

16 Product Stability Data Coordinator      

17 Annual Product Review Coordinator      

18 Approved Vendor List Coordinator      

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Technology Transfer Checklist for Sending Plant

Sr Activity / Documents * Responsible # Probable Target Sent Sent

. person date on by

19 Audit Report of vendors Coordinator

(Manufacturer)      

20 Product History (Critical Coordinator

product problems)      

21 Complaint History and Coordinator

Investigation report      

22 Change control / History of Coordinator

product.      

23 Technical Agreement Coordinator

24 Access letters / Marketing Coordinator

authorization

25 Dossiers transfer letters. Coordinator

26 Country’s FDA approval letter Coordinator