2. Index.
Introduction
Definition
GENERAL PRINCIPLES OF TECHNOLOGY TRANSFER (TT)
TECHNOLOGY TRANSFER PROTOCOLS
STEP INVOLVED IN TT
METHODS OF TECHNOLOGY TRANSFER
Checklist for Technology Transfer
AGENCIES FOR TECHNOLOGY TRANSFER IN INDIA
3. INTRODUCTION
It is a structural guideline which is intended for
quality of the process, products,
standardization and cost-effective productions.
Technology is the process by which a
developer of technology make its technology
available to a commercial partner that will
exploit the technology.
4. DEFINITION
As per World Health Organization, technology
transfer 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.”
In pharmaceutical industry, Technology Transfer
referce to the process of successful progress from
drug discovery to product development ,clinical trils
and ultimately fullScale commercialization.
5. GENERAL PRINCIPLES OF TECHNOLOGY
TRANSFER (TT)
The basic requirements of TT are:
A. Quality Risk Management (QRM)
B. Documented approach
C. Logical approach
D. Skilled and trained staff
E. Sending Unit (SU)
F. Receiving Unit (RU)
6. TECHNOLOGY TRANSFER PROTOCOLS
The following steps should be followed as per the transfer protocols
Purpose and objective of the transfer.
Scope of the transfer.
Skilled personnel and their responsibilities.
Comparison of materials, equipments and methods between SU and RU.
Assessment of experimental process for manufacturing.
Information of different batches.
Process validation.
Assessment of out of specification.
Analysis of finished products.
Documented reports of analysis.
7. STEP INVOLVED IN TT
Research phase
Development Phase
Production phase
Documentation
8. 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
9. CONTENT OF TTD
Master formula card
Master formula
Master packaging card
Development report
Standard test procedures and specifications
REASON FOR TECHNOLOGY TRANSFER
Lack of resource for manufacturing capacity
Lack of resource related to marketing and distribution capabilities
Lack of resource for commercial launch of products
Lack of resource for conducting clinical trials
Lack of resources for the exploitation of technology
10. TYPES OF TECHNOLOGY TRANSFER
There are 5 types of technology transfer:-
1. Technology transfer between private sector of the
same country.
2. Technology transfer from the government sector
to private sector.
3. Between private firms of different countries.
4. From academia to the private sector.
5. Academia, government and industry
collaborations.
11. METHODS OF TECHNOLOGY TRANSFER
Licensing
Support contract
Joint venture
Franchising
strategic alliance
Buy back contract original equipment manufacture
12. WHO GUIDELINE FOR TECHNOLOGY TRANSFER
Guidelines are mentioned in Annexure 7 of WHO
technical report series no. 961,2011 as who
guidelines on transfer of technology in
pharmaceutical manufacturing
13. CHECKLIST FOR TECHNOLOGY TRANSFER
Production master formula
Manufacturing and dispensing instruction
Analytical method
Cleaning instructions and previous cleaning validation
Active specifications and source
Packaging instructions
Speciman manufacturing batch record
14. INFORMATION REQUIRED FOR TECHNOLOGY
TRANSFER
Starting Materials
A. Active Pharmaceutical Ingredients (API)
Information may include the following-
Open part- applicant part.
Closed part- have confidential information
B. Excipients
Used in the process of manufacturing have an important role in quality of the finished product.
Some of the examples of detail information
Details of manufacturer and supplier.
Category of excipients.
Dosage form available.
Descriptions.
Solubility.
15. Finished pharmaceutical Products
The information includes-
Qualitative and quantitative composition
Physical information.
Meathod of mfg
Safety and handling details
Packaging
Important instructions
Suitable container
Proper closure system
Packing material
Process of packaging
Design of packaging
Proper labeling
16. Documentation
Important documents required in technology transfer are:
Technology transfer protocol, qualification protocol
and report.
Training protocols and report.
Standard Operating Procedure (SOP).
Technology transfer report.
Analytical methods transfer protocol
Premises
Equipment
Qualification and Validation
17. AGENCIES FOR TECHNOLOGY TRANSFER IN
INDIA
Asian and Pacific Centre for Transfer of Technology (APCTT)
National Research Development Corporation (NRDC)
Technology Information, Forecasting & Assessment Council
(TIFAC)
Biotech Consortium India Limited (BCIL)
Technology Bureau for Small Enterprises (TBSE)
Small industrial Development Bank of India (SIDBI)
