1. Technology Transfer:
(1) WHAT IS TECHNOLOGY TRANSFER?
Transfer of technology is defined as “a logical procedure that controls the transfer of any process
together with its documentation and professional expertise between development and
manufacture or between manufacture sites” .
(2)TECHNOLOGY TRANSFER TEAM The technology transfer team consists of – R&D Process
Technologist – QA Representative – Production Representative – Engineering Representative –
QC Representative.
(3)WHEN TECHNOLOGY TRANSFER IS DONE?
 Process development at Lab (Bench scale)
 Scale up to R&D (1 Kg)
 R&D Lab to Pilot Plant
 Pilot plant to manufacturing ( Final commercial scale batch size)
(4) Detail engineering by project, MOC, mass balance, Energy balance, PFD, plant layout, P&ID.
(5)TECHNOLOGY TRANSFER PROCESS The processes are classified into the three
categories. • Research Phase – Quality by design • Development Phase – Consistency between
Quality and Specification – Assurance of consistency through development and manufacturing –
Technology Transfer from R&D to Production • Production Phase – Validation & Production –
Feedback from Production.
(6)Technology transfer from R&D to production (Development Phase)
(a) R&D provides technology transfer dossier (TTD) document to product development
laboratory, which contains all information like Batch size , SOP, MSDS, shelf life.
(b) Gives information about packaging type, material used for packaging, stability profile and
shelf life of packaging. (Process order and environment conditions)
(c) Specifications and Standard Test Procedures (STP’S)– Helps to know active ingredients and
excipients profile, in-process parameters, product release specifications and finished product
details.
TECHNOLOGY TRANSFER PROCEDURE : Procedure for Manufacturing and Packaging:
After the completion of three validation/commercial batches, R&D shall prepare the technology
transfer dossier (TTD), which shall be reviewed by Head- Production, Head-QC, Head-
Engineering and approved by Head-QA.
• The dossier shall contain the details of unitary formula, process flow chart, raw material and
packing material specifications, in-process and finished product specifications, master formula
card, safety parameters, critical process steps, critical process parameters and their
specifications and measured response, process validation protocol, process validation report,
stability data, deviation and change controls, product development report.

2. • After successful transfer of technology (manufacturing process), manufacturing of the
respective product is the responsibility of production department. If any problem arises, QA shall
investigate and refer to R&D through investigation report in the form of Inter Office
Communication.
• Trouble shouting : Any abnormal condition like quality, un reacted in reaction ,%yield.
•manufacturing process shall be demonstrated to production personnel on minimum of 3 or 10
batches.