Technology transfer

Views:
 
     
 

Presentation Description

No description available.

Comments

Presentation Transcript

TECHNOLOGY TRANSFER PROCESS IN PHARMACEUTICAL INDUSTRIES:

TECHNOLOGY TRANSFER PROCESS IN PHARMACEUTICAL INDUSTRIES

WHAT IS TECHNOLOGY TRANSFER?:

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” Technology transfer is both integral and critical to the drug discovery and development process for new medicinal products.

REASON FOR TECHNOLOGY TRANSFER::

REASON FOR TECHNOLOGY TRANSFER: Forming alliances with partners that can progress the development of the technology to take it to market. Forming alliances with partners with manufacturing capability. Forming alliances with partners with marketing and distribution capability. Exploitation in a different field of application.

WHEN TECHNOLOGY TRANSFER ?:

WHEN TECHNOLOGY TRANSFER ? Idea to Discovery Lab Discovery Lab to Development Lab Development Lab to Pilot Plant Kilo Lab to Pilot Plant Pilot Plant to Semi-works (other pilot plant) Pilot Plant to Manufacturing Manufacturing to Manufacturing

IMPORTANCE OF TECHNOLOGY TRANSFER:

IMPORTANCE OF TECHNOLOGY TRANSFER To elucidate necessary information from R&D to actual manufacturing To elucidate necessary information of existing products between various manufacturing places; To exemplify specific procedures and points of concern for the two types of technology transfer in the above to contribute to smooth technology transfer. This is applies to the technology transfer through R&D and production of drug and the technology transfer related to post-marketing changes in manufacturing places.

TECHNOLOGY TRANSFER PROCESS:

TECHNOLOGY TRANSFER PROCESS The processes are classified into the three categories. Research Phase Quality by design Development Phase Research for Factory Production Consistency between Quality and Specification Assurance of consistency through development and manufacturing Technology Transfer from R&D to Production Production Phase Validation & Production Feed back from Production and Technology Transfer of Marketed Products

TECHNOLOGY TRANSFER TEAM:

TECHNOLOGY TRANSFER TEAM The technology transfer team consists of R&d Process Technologist QA Representative Production Representative Engineering Representative QC Representative

TECHNOLOGY TRANSFER DOCUMENATION:

TECHNOLOGY TRANSFER DOCUMENATION Organization for Technology Transfer Research and Development Report Product Specification File Technology Transfer Plan Technology Transfer Report Verification of Results of Technology Transfer

TECHNOLOGY TRANSFER CHECKLIST:

TECHNOLOGY TRANSFER CHECKLIST It consists of Production master formula, Manufacturing instructions, Dispensing instructions, Analytical methods, Previous process validation, Previous analytical validation, Cleaning instructions and previous cleaning validation, Stability reports, Excipient specifications and source, Active specifications and source, Primary packaging material specifications and source, Packaging instructions, Process deviations file, Analytical deviations file, Reject and rework file, Specimen manufacturing batch record.

Success of Technology Transfer:

Success of Technology Transfer Its depends on Communication Open communication between all team members Direct communication between technical members Effective and timely communication with regulators Sending and Receiving Unit Technology transfer is not a “one way street” The sending unit and receiving unit must be equally involved in the process to ensure success Team work at all time

authorStream Live Help