1. The document discusses qualitative and quantitative models of technology transfer. Qualitative models delineate activities and factors that influence success, while quantitative models aim to quantify parameters and minimize incompatibility between transferors and transferees.
2. Several qualitative models are described, including the Bar-Zakay, Behrman and Wallender, Dahlman and Westphal, and Schlie, Radnor and Wad models. These models outline stages of the technology transfer process and factors that influence effectiveness.
3. Quantitative models discussed aim to measure parameters like potential technological distance between transferors and transferees, and examine the technological "catch-up" process when a leader assists a follower.
Qualitative and Quantitative Technology Transfer Models...
This topic comes under Product Development and Technology Transfer....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in Fist year sem I....
This Presentation Contain following...
#Introduction of Technology Transfer
#Types of Technology Transfer
#Importance, Reasons of Technology Transfer
#Models of Technology Transfer
#Conclusion
#References
Thanks For Help and Guidance of Mr. Rakesh P. Dhawale Sir
and Miss. Sadaf A. Mutwalli
A proper technology transfer (TT) is both essential and important to drug discovery and development for new medicinal products. It is also required to upgrade drug quality planned during research development and to final product during manufacturing as well as to guarantee that stable quality is transferred
Transferring of details related to formulation and analytical strategies from one area to another area i.e. from R&D to production department and transferring of resulting product from lab scale to production scale. It’s a organized procedure including documented information and knowledge gained throughout the development. In pharmaceutical industry technology transfer includes steps from drug discovery to product development, clinical trials and full scale commercialization. According to WHO it’s a logical procedure that controls the transfer of any method along with its documentation and professional expertise between development and manufacturer.
Qualitative and Quantitative Technology Transfer Models...
This topic comes under Product Development and Technology Transfer....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in Fist year sem I....
This Presentation Contain following...
#Introduction of Technology Transfer
#Types of Technology Transfer
#Importance, Reasons of Technology Transfer
#Models of Technology Transfer
#Conclusion
#References
Thanks For Help and Guidance of Mr. Rakesh P. Dhawale Sir
and Miss. Sadaf A. Mutwalli
A proper technology transfer (TT) is both essential and important to drug discovery and development for new medicinal products. It is also required to upgrade drug quality planned during research development and to final product during manufacturing as well as to guarantee that stable quality is transferred
Transferring of details related to formulation and analytical strategies from one area to another area i.e. from R&D to production department and transferring of resulting product from lab scale to production scale. It’s a organized procedure including documented information and knowledge gained throughout the development. In pharmaceutical industry technology transfer includes steps from drug discovery to product development, clinical trials and full scale commercialization. According to WHO it’s a logical procedure that controls the transfer of any method along with its documentation and professional expertise between development and manufacturer.
Technology Transfer and Scale-up in Pharmaceutical IndustryPranjalWagh1
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”.
In Pharmaceutical Industry, technology transfer refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials to full scale commercialization.
It is basically divided into three phases - Research Phase, Development Phase and Production Phase. The presentation elaborates on the technology transfer taking place in production phase. Production phase mainly concerns with validation studies and scale-up.
Validation studies such as performance qualification, cleaning validation and process validation is carried out by R&D department.
Scale-up involves the use of results obtained from lab studies for designing prototype of a product and pilot plant process, constructing pilot plant and further using pilot plant data for full-scale commercialization.
NEW ERA OF DRUG PRODUCT: OPPORTUNITIES AND CHALLENGESganpat420
Abstract
Introduction
Global pharmaceutical industry
Indian pharmaceutical industry
Indian Pharmaceutical Market
Opportunities
Challenges
Conclusion
References
Manufacturing Control Systems. J R Controls provides control systems for the manufacturing industry. A typical control system will monitor the progress of parts through the manufacturing and finishing process.
ANALYSIS OF RAW MATERIALS, FINISHED PRODUCTS, PACKAGING MATERIALS, IPQC, CPCS...Khadeeja6
RAW MATERIALS
It is basically the chemical ingredients of a process. starting material, in production of final product.
FINISHED PRODUCTS
Marketable product, transportable pack, salable pack
PACKAGING MATERIAL
Providing presentation, protection, identification, information, containment, convenience compliance, integrity and stability for a product during storage, transportation display and until it is consumed or throughout its shelf life.
IPQC
Providing accurate, specific and definite description of the procedures to be employed from the receipt of raw materials to the release of the finished dosage form.
CPCSEA GUIDELINES
Role of CPCSEA is to monitor animal experiments through ethics committees set up in institutions (IAEC)
CPCSEA Nominee -important link between CPCSEA and IAEC
IAEC scrutinize all project proposals for experimentation on animals.
The validity of IAEC is for 3 years.
Technology transfer by Zade Manasi S. M pharm 1st yr, Bharati vidyapeeth College of pharmacy, Kolhapur .
1. Introduction :-Technology transfer is the practice of transferring scientific findings from one organization to another for further development.
Which is mainly concerned with the transfer of technology from research areas to “Production and Quality Assurance” environment.
The process by which existing knowledge, facilities or capabilities developed under R & D are utilized to fulfil public and private need.
Technology transfer is the intersection between business, science, engineering, law and government.
Definition :-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” .
3. Objective :-To offer guidance & assistance to inventors & corporation.
-To provide a hands-on learning opportunity.
-To increase the general awareness.
-To accelerate scale-up and cost reduction.
4. Development of technology from Research & D to production :-R&D provides technology transfer dossier (TTD) document to product development laboratory, which contains all information of formulation and drug product as follows-
Master Formula Card (MFC)– Includes product name along with its strength, generic name, MFC number, page number, effective date, shelf life and market.
Master Packing Card– Gives information about packaging type, material used for packaging, stability profile and shelf life of packaging.
Master Formula–
5. Success of technology transfer :-It 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
6. Checklist for technology transfer :-It consists of:
Production master formula.
Manufacturing and Dispensing instructions.
Analytical methods.
Cleaning instructions and previous cleaning validation.
Active specifications and source.
Primary packaging material specifications and source.
Packaging instructions.
Process deviations file, Analytical deviations file.
Specimen manufacturing batch record.
7. Technology transfer team :- The technology transfer team consists of :
Process Technologist
QA Representative
Production Representative
Engineering representative
QC Representative
8. Steps in technology transfer process :-A] Development of technology by R&D( Reaserch Phase):
(a) Design of procedure and selection of excipients by R&D
(b) Identification of specifications and quality by R&D
B] Technology transfer from R&D to production (Development Phase):
(a)Master Formula Card (MFC)
(b) Master Packing Card
(c) Master Formula
(d) Specifications
Technology Transfer and Scale-up in Pharmaceutical IndustryPranjalWagh1
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”.
In Pharmaceutical Industry, technology transfer refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials to full scale commercialization.
It is basically divided into three phases - Research Phase, Development Phase and Production Phase. The presentation elaborates on the technology transfer taking place in production phase. Production phase mainly concerns with validation studies and scale-up.
Validation studies such as performance qualification, cleaning validation and process validation is carried out by R&D department.
Scale-up involves the use of results obtained from lab studies for designing prototype of a product and pilot plant process, constructing pilot plant and further using pilot plant data for full-scale commercialization.
NEW ERA OF DRUG PRODUCT: OPPORTUNITIES AND CHALLENGESganpat420
Abstract
Introduction
Global pharmaceutical industry
Indian pharmaceutical industry
Indian Pharmaceutical Market
Opportunities
Challenges
Conclusion
References
Manufacturing Control Systems. J R Controls provides control systems for the manufacturing industry. A typical control system will monitor the progress of parts through the manufacturing and finishing process.
ANALYSIS OF RAW MATERIALS, FINISHED PRODUCTS, PACKAGING MATERIALS, IPQC, CPCS...Khadeeja6
RAW MATERIALS
It is basically the chemical ingredients of a process. starting material, in production of final product.
FINISHED PRODUCTS
Marketable product, transportable pack, salable pack
PACKAGING MATERIAL
Providing presentation, protection, identification, information, containment, convenience compliance, integrity and stability for a product during storage, transportation display and until it is consumed or throughout its shelf life.
IPQC
Providing accurate, specific and definite description of the procedures to be employed from the receipt of raw materials to the release of the finished dosage form.
CPCSEA GUIDELINES
Role of CPCSEA is to monitor animal experiments through ethics committees set up in institutions (IAEC)
CPCSEA Nominee -important link between CPCSEA and IAEC
IAEC scrutinize all project proposals for experimentation on animals.
The validity of IAEC is for 3 years.
Technology transfer by Zade Manasi S. M pharm 1st yr, Bharati vidyapeeth College of pharmacy, Kolhapur .
1. Introduction :-Technology transfer is the practice of transferring scientific findings from one organization to another for further development.
Which is mainly concerned with the transfer of technology from research areas to “Production and Quality Assurance” environment.
The process by which existing knowledge, facilities or capabilities developed under R & D are utilized to fulfil public and private need.
Technology transfer is the intersection between business, science, engineering, law and government.
Definition :-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” .
3. Objective :-To offer guidance & assistance to inventors & corporation.
-To provide a hands-on learning opportunity.
-To increase the general awareness.
-To accelerate scale-up and cost reduction.
4. Development of technology from Research & D to production :-R&D provides technology transfer dossier (TTD) document to product development laboratory, which contains all information of formulation and drug product as follows-
Master Formula Card (MFC)– Includes product name along with its strength, generic name, MFC number, page number, effective date, shelf life and market.
Master Packing Card– Gives information about packaging type, material used for packaging, stability profile and shelf life of packaging.
Master Formula–
5. Success of technology transfer :-It 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
6. Checklist for technology transfer :-It consists of:
Production master formula.
Manufacturing and Dispensing instructions.
Analytical methods.
Cleaning instructions and previous cleaning validation.
Active specifications and source.
Primary packaging material specifications and source.
Packaging instructions.
Process deviations file, Analytical deviations file.
Specimen manufacturing batch record.
7. Technology transfer team :- The technology transfer team consists of :
Process Technologist
QA Representative
Production Representative
Engineering representative
QC Representative
8. Steps in technology transfer process :-A] Development of technology by R&D( Reaserch Phase):
(a) Design of procedure and selection of excipients by R&D
(b) Identification of specifications and quality by R&D
B] Technology transfer from R&D to production (Development Phase):
(a)Master Formula Card (MFC)
(b) Master Packing Card
(c) Master Formula
(d) Specifications
Technology Transfer in Pharma Industry, Technology Transfer in Pharmaceutical Industry, Pharmaceutical Technology Transfer, Pharma Tech Transfer, Naseeb basha, Pharmaceutical Tech Transfer, Naseeb basha Technology Transfer in Pharma Industry, Naseeb basha Pharmaceutical Technology Transfer
technology transfer of liquid oral and supac guidelines ASHISH SUTAR
logical procedure that controls the transfer of any process together with its documentation and professional expertise between developments or between manufacture sites.
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How to evaluate maturity of your Technology? Is your technology can be commercialized? Is it worth to patent your technology? When to start looking for licensing or selling your technology? When to start a venture from your technology?
The Roman Empire A Historical Colossus.pdfkaushalkr1407
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This is a presentation by Dada Robert in a Your Skill Boost masterclass organised by the Excellence Foundation for South Sudan (EFSS) on Saturday, the 25th and Sunday, the 26th of May 2024.
He discussed the concept of quality improvement, emphasizing its applicability to various aspects of life, including personal, project, and program improvements. He defined quality as doing the right thing at the right time in the right way to achieve the best possible results and discussed the concept of the "gap" between what we know and what we do, and how this gap represents the areas we need to improve. He explained the scientific approach to quality improvement, which involves systematic performance analysis, testing and learning, and implementing change ideas. He also highlighted the importance of client focus and a team approach to quality improvement.
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Technology transfer models.pptx
1. PES
MODERN COLLEGE OF PHARMACY (Ladies)
MOSHI, PUNE
Savitribai Phule Pune University
B.PHARM
Semester- VII
By
Mrs. Sneha Patil
Assistant Professor
Dept. of Pharmaceutics
Technology transfer models
– Qualitative and quantitative models
3. 1. Introduction
Technology transfer is the process by which the manufacturing
process and analytical method are transferred from one
manufacturing unit to another unit or from R & D to manufacturing
unit
Technology transfer from R & D to manufacturing site is critical
because of the scale up of the product from pilot batch to large scale
commercial batch
In pharmaceutical industry, “Technology Transfer” refers to the
processes of successful progress from drug discovery to product
development, clinical trials and ultimately full-scale
commercialization
4. Introduction continue……
Models of technology transfer that could facilitate the effective
planning and implementation of technology transfer projects
Two types of technology transfer models are qualitative and
quantitative
Qualitative models often have as their objective the delineation of
activities involved in managing technology transfer and the elicitation
of factors and issues that can influence the success and/or
effectiveness of technology transfer
Quantitative models, aim at quantifying parameters of significance in
technology transfer and analysing them with a view towards
minimizing goal incompatibility between the transferors and
transferees of technology
5. Introduction continue…..
Classification of technology transfer models
Sr. No. Qualitative models Quantitative models
1. The Bar-Zakay model Sharif and Haq
2. The Behrman and Wallender model Raz et al
3. The Dahlman and Westphal model Klein and Lim
4. The Schlie, Radnor and Wad model
5. Lee et al.
6. The Chantramonklasri model
7. Unido model
8. Durrani et al.
6. 2. Qualitative technology models
1. The Bar-Zakay model
Bar-Zakay (1971) developed a technology transfer model based on a
project management approach
Technology transfer process is divided into the Search, Adaptation,
Implementation and Maintenance stages
The lessons that can be learnt from the Bar- Zakay model are the
following:
1. There is a need for a comprehensive examination of the entire
technology transfer process from “search” right through to “post-
implementation” activities
2. The process approach must be adopted in planning and
implementing technology transfer projects
3. Milestones and decision points are important so that activities can
be strengthened, mistakes corrected, or even the project terminated
at any point in time
7. Qualitative technology models continue……
2. The Behrman and Wallender model
Behrman and Wallender (1976) have proposed a seven stage process
for international technology transfer that may be more relevant to
multinational corporations
The seven stages are:
1. Manufacturing proposal and planning to arrive at decisions
regarding location and preparing a business case including good
resource assessments
2. Deciding the product design technologies to be transferred
3. Specifying details of the plant to be designed to produce the product
and other aspects related to construction and infrastructure
development
4. Plant construction and production start-up
8. Qualitative technology models continue……
2. The Behrman and Wallender model
5. Adapting the process and product if needed and strengthening
production systems to suit local conditions
6. Improving the product technology transferred using local skills
7. Providing external support to strengthen the relationship between
the transferor and transferee
Weakness of this model – During first three stages, the transferor
develops the technology transfer project with minimal involvement
of the transferee thereby reinforcing dependency
9. Qualitative technology models continue……
3. The Dahlman and Westphal model (1981)
He proposed a nine stage process model as follows:
1. Pre-investment feasibility is carried out to gather information and
establishing project viability that are carried out for techno-
economic
2. On the basis of feasibility study there is a need to carry out a
preliminary identification of technologies
3. Carry out basic engineering studies that involve the preparation of
process flow diagrams, layouts, material and energy balances and
other design specifications of the plant and machinery and the core
technology to be transferred
4. To make the transfer effective carry out a detailed engineering study
that involve the preparation of a detailed civil engineering plan for
the facility, including construction and installation specifications and
identification of the peripheral technology needed
10. Qualitative technology models continue……
3. The Dahlman and Westphal model (1981)
He proposed a nine stage process model as follows:
5. Selection of suppliers to assemble the plant machinery, equipment
and plan for the co- ordination of the work among various parties
6. The education plan and training are executed in consultation with
the suppliers of technology for the workers who would be employed
in the technology transfer project
7. The plant is constructed
8. Operations are commenced
9. Develop trouble-shooting skills and put in place arrangements to
solve design and operational problems as they arise, especially
during the early years of operation
Weakness of the model – It assumes that the transferee will have
access to high level engineering skills
11. Qualitative technology models continue……
4. The Schlie, Radnor and Wad model
Schlie et al. (1987) propose a simple, generic model that delineates
seven elements that can influence the planning, implementation and
eventual success of any technology transfer project. These seven
elements are listed below.
i. The transferor, which is the unit selling the technology to the
recipient.
ii. The transferee, which is the unit buying the technology.
iii. The technology that is being transferred.
iv. The transfer mechanism that has been chosen to transfer the
chosen technology.
v. The transferor environment is the immediate set of conditions,
in which the transferor is operating. Attributes of the transferor
environment that can influence the effectiveness of the transfer
process include, among others, economic status, business orientation
(inward versus outward), stability, attitude and commitment to the
transfer project, and operating policies.
12. Qualitative technology models continue……
4. The Schlie, Radnor and Wad model
Schlie et al. (1987) propose a simple, generic model that delineates
seven elements that can influence the planning, implementation and
eventual success of any technology transfer project.
These seven elements are as follows:
1. The transferor, which is the unit selling the technology to the
recipient
2. The transferee, which is the unit buying the technology
3. The technology that is being transferred
4. The transfer mechanism that has been chosen to transfer the chosen
technology
5. The transferor environment is the immediate set of conditions, in
which the transferor is operating and attributes of the transferor
environment that can influence the effectiveness of the transfer
process include, among others, economic status, business
orientation (inward versus outward), stability, attitude and
commitment to the transfer project, and operating policies
13. Qualitative technology models continue……
4. The Schlie, Radnor and Wad model
6. The transferee environment is the immediate set of conditions
under which the transferee is operating. Attributes of the transferee
environment that can influence the absorptive capacity of the
transferee include physical and organizational infrastructure, skills
availability, attitude and commitment to the transfer project,
technological status, business orientation (inward versus outward),
economic status and stability.
7. The greater environment which is surrounding both the transferor
and the transferee, there may be layers of this environment that are
sub-regional, regional and global and even if the immediate
operating environments of the technology transfer, if the layers of
the greater environment are not supportive, then cross-border and
international technology transfer could be adversely affected
14. Qualitative technology models continue……
5. Lee at al.
He has developed a longitudinal model (1988) of technology transfer
based on a study of developing and rapidly industrializing countries
The need of transferee firm to put in place strategies to be able to go
through the stages of acquisition, assimilation, and eventual
improvement
15. Qualitative technology models continue……
6. The Chantramonklasri model
Chantramonklasri (1990) who proposes a five phase model as shown
in (Fig. 1)
The five phases of this model are as follows:
Fig. 1 Five –Phase Model of International Technology Transfer
16. Qualitative technology models continue……
6. The Chantramonklasri model
The five phases of this model are as follows:
1. Carrying out a pre-investment and feasibility study
2. On the basis of feasibility study developing engineering
specifications and design
3. Commence capital goods production based on the engineering
specifications and designs that have been developed
4. Commissioning and start-up including comprehensive of the
workforce
5. Commercial production commences
17. Qualitative technology models continue……
7. Unido model
UNIDO (1996) model, in which endorsement of the Bar- Zakay
approach, suggests that in the manufacturing sector, once the need
for a technology transfer project is established the steps of search,
evaluation, negotiation, contract execution, technology adaptation
and absorption should be followed sequentially to ensure
effectiveness
18. Qualitative technology models continue……
8. Durrani et al.
Durrani et al. (1998) have proposed a generic model consisting of five
steps:
1. Market-place requirements to be established
2. Identifying technology solutions
3. Classifying the identified technology solutions
4. Establishing sources from where the desired technology could be
acquired
5. Technology-acquisition decision was finalized
19. 3. Quantitative technology transfer models
1. Sharif and Haq
Sharif and Haq (1980) proposed the concept of Potential
Technological Distance (PTD) between a transferor and transferee
and argues that when the PTD is either too great or too small
between the transferor and transferee, the effectiveness of the
transfer is low
It suggests that when a transferee first looks for a potential transferor
it is important to look for one with an “optimal” PTD
20. Quantitative technology transfer models continue…..
2. Raz et al.
Raz et al (1983) have presented a model of technological “catch-up”
that shows how a technology leader, through technology transfer, can
assist the rate of technological development of a technology follower
The model examines three phases of growth of a technology follower
namely, the slow initial phase with high technological capability gap,
the faster learning phase with the decreasing gap, and catch-up
phase when the technological gap is very small or closed
21. Quantitative technology transfer models continue…..
3. Klein and lim
Klein and Lim (1997) have studied the technology gap between the
general machinery and electrical and electronic industries of Korea
and Japan
This model suggests that technology transfer from leaders can play a
critical role in upgrading the technological levels of follower firms
Their study also shows that the followers should supplement the
transfer by independently putting in place measures to assimilate,
modify, and localize the technology transferred from the leader