Page 1 of 2

Technology Transfer Checklist for Sending Plant

Project Identification No.

Name of Product :
Technology Sending Coordinator :
Technology Receiving Coordinator
(Proposed site )

Sl. Activity / Documents * Responsible # person Probable Target date Sent on Sent by
1 Product Developmental report Coordinator
2 Master Manufacturing Record / Batch Coordinator
manufacturing record (Executed)
3 Master Packing Record / Batch packing Coordinator
record (Executed) .
4 Tooling Specification Coordinator
5 Process Validation Protocol & Report Coordinator
6 Product Cleaning Method – Protocol & Coordinator
report
7 Specification, STP & MSDS of Active Coordinator
Material(s)
8 Specification, STP & MSDS of Inactive Coordinator
Material(s)
9 Specification, STP & MSDS of Coordinator
Packaging Material(s)
10 Specification, STP of In-process Coordinator
product(s)
11 Specification, STP & MSDS of Finished Coordinator
product (s)
12 Analytical method validation Protocol Coordinator
& Reports (Finished product) (as
applicable)
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
 Page 2 of 2
Technology Transfer Checklist for Sending Plant

Sl. Activity / Documents * Responsible # person Probable Target date Sent on Sent by
19 Audit Report of vendors (Manufacturer) Coordinator
20 Product History ( Critical product Coordinator
problems)
21 Complaint History and Investigation Coordinator
report
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