It can be used:

i. Before patenting the technology

ii. After patenting the technology

Information is not considered as confidential if:

i. It is in public domain by any means and entered in the public domain other than

the fault of the receiving party.

ii. If the disclosing party has access to its disclosure to the third party without

restriction.

iii. It is developed independently by the receiving party.

iv. It has to be disclosed by laws and regulations.

Main characteristics of confidentiality agreement:

i. Each “provider” retains all ownership rights in its information.

ii. Information can also include tangible objects.

iii. Provides for disposition of the information at the termination of the agreement

iv. Duration is up to the parties

v. No warranties on use of the information

vi. No implied license or other use beyond that expressly defined

100 Industrial Pharmacy II

vii. The recipient may be relieved of obligation if the information becomes public

through no fault of their own

viii. The recipient may be required to divulge information to a Court of Law

ix. Penalties defined for breach of confidentiality

Checklist for confidential agreements

1. Parties: Ensure that correct legal name and address is used.

2. Recitals: Describe the specific situation of the disclosure of confidential information.

Recitals may not be legally binding.

3. Subject of the agreement/information: Ensure that the subject matter and purpose

of the disclosed information is correctly identified and described.

4. Scope of confidential information: Check interests of both parties.

5. Use of the information by receiving party: Add obligation to keep the information

confidential, not disclose to third parties without prior written consent and to use it

only for the defined purpose.

6. Term and termination: Effective date for start of the contract and its time limit

should be mentioned.

7. Governing law and jurisdiction: Mention recommended law and jurisdiction in

case of breach of conditions in the agreement.

8. Miscellaneous: Wording to clarify that neither party is obliged to negotiate or enter

into any further agreement or any other condition, if needed.

9. Signatures: Signatures of both the parties/witnesses/any other designated authority

should be there.

6.5.2 Licensing

In this type the owner/developer of the technology grants permission to another

company (receiver/absorber) in the form of license to use the technology for certain

purposes and for a certain period (Fig. 6.4).

Fig. 6.4: Types of licensing agreement

Regulation of Transfer of Technology 101

By a technology licensing agreement the licensor authorizes the licensee to use the

technology under certain agreed terms and conditions. It is, therefore, a contract freely

entered into between two parties and contains terms and conditions so agreed.

The rights conferred by the license are as follows:

i. Technology/patent: To make, sell, import, export, use

 

i. Technology transfer

ii. Project consultancy

iii. Certification services

iv. Information services

v. Biosafety

vi. Biotech industrial training programme

vii. Project management

viii. DBT JRF

ix. DBT BINC (bioinformatics national certification)

Fig. 6.3: BCIL methodology for technology transfer

98 Industrial Pharmacy II

6.4.5 TBSE (Technology Bureau for Small Enterprises)/SIDBI (Small Industries

Development Bank of India)

The technology bureau for small enterprises under Ministry of Micro, Small and

Medium enterprises provides a platform for small enterprises that can tap opportunities

at the global level for the acquisition of technology or establish business collaboration.

Resulting from the joint initiative of the United Nations' Asian and Pacific Centre for

Transfer of Technology and Small Industries Development Bank of India which

represents under one roof the synergy of technology and finance.

Small Industries Development Bank of India (SIDBI), set up on April 2, 1990, under

an Act of Indian Parliament, presently acts as the principal financial institution for the

promotion, financing and development of the micro, small and medium enterprise

(MSME) sector and also co-ordinates the functions of the institutions engaged in similar

activities. As on March 31, 2012, the authorised capital of SIDBI is 1000 crore and

paid-up capital is 450 crore. Presently, the Bank provides refinance support through a

network of eligible member lending institutions for onward lending to MSMEs and

direct assistance is channelized through the Bank’s branch offices. SIDBI also extends

financial assistance in the form of loans, grants, equity and quasi-equity to nongovernment organisations/micro finance institutions (MFIs) for on-lending to micro

enterprises and economically weaker sections of the society, enabling them to take up

income-generating activities on a sustainable basis.

The important features of TBSE services are:

i. Offers a professionally managed system for technology and collaboration search.

ii. Helps in building up confidence between prospective partners.

iii. Lends a friendly hand in the intricate task of negotiations and matching of

perceptions.

iv. Provides a gateway to the global technology market through networking.

v. Unique mechanism for arranging technology and finance.

vi. Takes up project appraisal and preparation of a business plan.

 

In November 1993, the TIFAC Governing Council felt that the dream for a developed

India can only be realized through technological strength. TIFAC took up the

responsibility of creating a Technology Vision for the country that would catalyze and

guide national initiatives in Science and Technology.

The objectives of the exercise were:

i. To provide directions for national initiatives in science and technology to realize

a vision for India up to 2020

ii. To provide a strong basis for policy framework and investment for R&D in the

government and the private sector

iii. To contribute to the development of an integrated S&T policy both at the state

and national levels.

The nationwide exercise spanned over three years and includes:

i. 7 task forces and

ii. 10 panels drawing 500 experts from industry

iii. Government and R&D institutions.

iv. About 5000 experts from across the country participated in the exercise through

their responses to questionnaires, workshops, etc.

The task forces covered areas of agro-food processing, waterways, road

transportation, civil aviation, electric power, telecommunications and advanced

sensors. The panels were on food and agriculture, engineering industries, healthcare,

life sciences and biotechnology, materials and processing, service, strategic industries,

electronics and communication, chemical process industries, and driving forces and

impedances.

Regulation of Transfer of Technology 97

The technology vision 2020 reports provided the technology status, forecasts

and assessment of respective sectors. They also identified short-, medium- and

long-term technology priorities for the country and suggested ways to implement

them.

6.4.4 BCIL (Biotech Consortium India Limited)

BCIL was inaugurated in 1990 by the then Prime Minister of India, Hon'ble Shri Chandra

Shekhar. Biotech Consortium India Limited (BCIL) is a public limited company,

promoted by the Department of Biotechnology (DBT), Ministry of Science and

Technology, Government of India and all India financial institutions for providing the

necessary linkages among stakeholders and business support for facilitating accelerated

commercialization of biotechnology.

The Board of Directors of BCIL consists of senior representatives of DBT, Council of

Scientific and Industrial Research (CSIR), Indian Council of Agricultural Research

(ICAR), leading all India financial institutions and the biotechnology industry.

The office of BCIL is at Biotech Consortium India Limited, V Floor, Anuvrat Bhawan,

210, Deen Dayal Upadhyay Marg, New Delhi 110002.

Functions

BCIL has been actively involved in technology transfer, project consultancy, fund

syndication, information dissemination, and manpower training and placement related

to biotechnology over the last decade and a half.

It has assisted hundreds of clients including scientists, technologies, research

institutions, universities, first entrepreneurs, the corporate sector, national and

international organizations, central government, various state governments, banks and

financial institutions. Services offered by BCIL (Fig 6.3)

 

i. Technology transfer

ii. Project consultancy

iii. Certification services

iv. Information services

v. Biosafety

vi. Biotech industrial training programme

vii. Project management

viii. DBT JRF

ix. DBT BINC (bioinformatics national certification)

Fig. 6.3: BCIL methodology for technology transfer

98 Industrial Pharmacy II

6.4.5 TBSE (Technology Bureau for Small Enterprises)/SIDBI (Small Industries

Development Bank of India)

The technology bureau for small enterprises under Ministry of Micro, Small and

Medium enterprises provides a platform for small enterprises that can tap opportunities

at the global level for the acquisition of technology or establish business collaboration.

Resulting from the joint initiative of the United Nations' Asian and Pacific Centre for

Transfer of Technology and Small Industries Development Bank of India which

represents under one roof the synergy of technology and finance.

Small Industries Development Bank of India (SIDBI), set up on April 2, 1990, under

an Act of Indian Parliament, presently acts as the principal financial institution for the

promotion, financing and development of the micro, small and medium enterprise

(MSME) sector and also co-ordinates the functions of the institutions engaged in similar

activities. As on March 31, 2012, the authorised capital of SIDBI is 1000 crore and

paid-up capital is 450 crore. Presently, the Bank provides refinance support through a

network of eligible member lending institutions for onward lending to MSMEs and

direct assistance is channelized through the Bank’s branch offices. SIDBI also extends

financial assistance in the form of loans, grants, equity and quasi-equity to nongovernment organisations/micro finance institutions (MFIs) for on-lending to micro

enterprises and economically weaker sections of the society, enabling them to take up

income-generating activities on a sustainable basis.

The important features of TBSE services are:

i. Offers a professionally managed system for technology and collaboration search.

ii. Helps in building up confidence between prospective partners.

iii. Lends a friendly hand in the intricate task of negotiations and matching of

perceptions.

iv. Provides a gateway to the global technology market through networking.

v. Unique mechanism for arranging technology and finance.

vi. Takes up project appraisal and preparation of a business plan.

 

The members and associate members elected by the commission shall be elected

for three years but shall be eligible for re-election. The executive secretary or

his/her representative shall attend meetings of the council.

iii. The director of the centre shall serve as secretary of the council. All member

states and associate members of UNESCAP are de facto members of APCTT.

iv. Representatives of: (a) States that are not members of the council, (b) United

Nations bodies and specialized and related agencies and (c) such other

organizations as the council may deem appropriate, as well as experts in fields of

interest to the council, may be invited by the Executive Secretary to attend

meetings of the council.

v. The council shall meet at least once a year and may adopt its own rules of

procedure. A quorum for meetings of the council shall be a majority of its

members.

vi. The council shall, at each regular session, elect a chair and vice-chair. They shall

hold office until the next regular session of the council. The chair or in his/her

absence, the vice-chair shall preside at meetings of the council. If the chair is

unable to serve for the full term for which he/she has been elected, the

vice-chair shall act as chair for the remainder of that term.

vii. The council shall advise on the formulation and implementation of the programme

of work of the centre and review the administration and financial status of the

centre. The Executive Secretary shall submit an annual report, as adopted by the

council, to the commission at its annual sessions.

Functions

i. APCTT promotes the technology transfer in the Asia-Pacific Region by its ICTbased networks, platforms and its advisory services.

ii. The main emphasis is on promoting cross-border business cooperation between

small and medium scale enterprises (SMEs) and facilitating technology-based

business partnerships.

Regulation of Transfer of Technology 93

It has Three Online Technology Support Mechanisms

1. Asia-Pacific Technology Transfer Market Service for SMEs: It acts as an information

exchange platform for SMEs related to technology transfer, it is free of cost service.

It gives information regarding:

i. The technology available for transfer

ii. Technology needed

iii. Opportunities for business cooperation

2. Global technology database: It has a technology database country-wise for SMEs

and entrepreneurs. It is an extended version and gives the desired result in case

Asia-Pacific Technology transfer market service for SMEs do not give.

3. Renewable energy technology bank (RET Bank): Its main objective is to facilitate

TT co-operation among countries in the Asia-Pacific region in the field of renewable

energy. It is data bank of Renewable Energy Technologies in area of solar, biomass,

hydro, wind, geothermal energy, etc. It is freely available for public access.

APCTT offers technology transfer promoting services to technology providers and

seekers. It is done by partnering with its technology transfer intermediary networks

and national focal points. Some important technology transfer facilitation services of

APCTT include:

 

i. Providing information on technology transfer, joint-venture, business/research

partnerships and opportunities.

ii. Organizing business-to-business meets.

iii. Technology exhibitions and technology transfer related conferences and

technology dissemination workshops in partnership with APCTT focal points in

the member countries.

iv. Providing support services to help techno-entrepreneurs interact with technology

transfer intermediaries, source technology globally, and also explore venture

capital financing.

6.4.2 NRDC

National Research Development Corporation (NRDC) was established in 1953 by the

Government of India. Its primary objective is to promote, develop and commercialise

the technologies /know-how/inventions /patents /processes emanate from various

national R&D institutions/universities. It is presently working under the administrative

control of the Department of Scientific and Industrial Research, Ministry of Science

and Technology.

Vision: To be a leading technology transfer organization in India.

Mission:

i. To promote, develop, nurture and commercialize innovative, reliable and

competitive technologies from R&D institutes through value addition and

partnership

ii. To sensitize R&D institutions and industry about technologies that need to be

developed and commercialized.

Organisational flowchart (Source: NRDC): Details shown in Flowchart 6.1

i. Minister: Dr. Harsh Vardhan, Hon’ ble Union Minister, Science and Technology

and Earth Sciences

ii. Secretary: Dr. Shekhar C. Mande, Director General, CSIR and Secretary, DSIR

(Note: The name of persons in the flowchart subjected to change from time to time)

94 Industrial Pharmacy II Flowchart 6.1: Organisational flowchart of NRDC

Regulation of Transfer of Technology 95

Achievements of NRDC

i. NRDC has developed strong links with the scientific and industrial community

in India and abroad.

ii. It developed a wide network of research institutions, academia and industry.

iii. It made formal arrangements with institutions, academia and industry for the

commercialisation of know-how developed in their laboratories

iv. It is now recognised as a large repository of a wide range of technologies spread

over almost all areas of industries, viz. agriculture and agro-processing, drugs

and pharmaceuticals, bio-technology, metallurgy, etc.

v. It has licensed the indigenous technology to more than 4800 entrepreneurs.

vi. NRDC has also successfully exported technologies and services to both developed

as well as the developing countries.

vii. NRDC is recognised, mainly in developing countries, as the source of reliable

appropriate technology, machines and services.

6.4.3 TIFAC (Technology Information Forecasting and Assessment Council)

As per the recommendation of Technology Policy Implementation Committee (TPIC)

in 1985, cabinet approved the formation of TIFAC in mid-1986 and TIFAC was formed

as a registered society in February 1988 under the Department of Science and

Technology as an autonomous body. The office of TIFAC is at Technology Information

Forecasting and Assessment Council, Department of Science and Technology (DST),

‘A’ Wing, Vishwakarma Bhavan, Shaheed Jeet Singh Marg, New Delhi 110016, India.

TIFAC activities encompass a wide array of technology areas and fill a critical gap

in the overall S&T system of India. The organization has carried out technology

foresight exercise, facilitated and supported technology development, prepared

technology linked business opportunity reports and implemented mission-mode

programmes.

 

It is Asian and Pacific Centre for Transfer of Technology works under United Nations

ESCAP (Economics and Social Commission for Asia and Pacific). The Asian and Pacific

Centre for Transfer of Technology, established on 16 July 1977. The Centre was

established in 1977 in Bangalore, India. In 1993, the Centre moved to New Delhi, India.

It was established under Economic and Social Commission for Asia and the Pacific

resolutions 159 (XXXI) of 6th March 1975 and 164 (XXXII) of 31st March 1976. The

membership of APCTT is identical to the membership of the Economic and Social

Commission for Asia and the Pacific. APCTT has the status of a subsidiary body of

ESCAP.

 Headquarter of APCTT, C-2, Qutab Institutional Area, New Delhi. The current

head of APCTT is Michiko Enomotov

92 Industrial Pharmacy II

Objectives

The objectives of the centre are:

i. To assist the members and associate members of ESCAP through strengthening

their capabilities to develop and manage national innovation systems;

ii. To develop, transfer, adapt and apply technology;

iii. To improve the terms of transfer of technology;

iv. To identify and promote the development and transfer of technologies relevant

to the region.

Governance

i. The centre shall have a governing council (hereinafter referred to as “the council”),

a Director and staff. The centre is located in New Delhi. The centre’s activities

shall be in line with relevant policy decisions adopted by the general assembly,

the economic and social council and the commission. The centre shall be subject

to the financial and staff regulations and rules of the United Nations and the

applicable administrative instructions.

ii. The centre shall have a governing council consisting of a representative designated

by the government of India and no fewer than eight representatives nominated

by other members and associate members of ESCAP elected by the commission.

 

DBT successfully transfer technology of forest trees through tissue culture. The

technology of teak is successfully transferred to the international plant laboratory,

UK. It is a landmark because it is first of its kind reverse transfer of tissue culture

technology from developing country to a developed country. Other than that MTP,

i.e. Micropropagation technology which is also established by DBT successfully

transferred the eucalyptus, populous and sugarcane technology to Cadila

Pharmaceuticals, Ahmedabad.

The pharmaceutical company named Cipla has several TT agreements with

pharmaceutical companies in Uganda, Egypt, Morocco, etc.

The investment and acquisition of Caraco Pharmaceuticals Laboratories by Sun

Pharma increases Caraco Pharmaceuticals sale and also establishes a new market. This

is only because of structured technology transfer from Sun Pharma to Caraco

Pharmaceuticals Laboratories.

There are also other examples involving TT like Shanta biotechnics has entered in

TOT for typhoid with IVI Korea, Themis laboratories entered in TT agreement with

Aventis Pharma for fixed-dose combinations of glibenclamide and glimipride with

metformin, Industrial Research and Consultancy Centre (IRCC) in IIT Mumbai also

developed several technologies in the field of engineering which are available for

transfer, the US multinational Eli-Lilly entered in TT agreement with Shasun Chemical

and Drug for manufacturing of know-how anti-TB drug, cycloserine

There is a never-ending list of technology transfer cases. This shows the importance

of TT in the recent scenario. In spite of barriers and challenges, it is all growing field.

6.4 TOT AGENCIES IN INDIA

The process of technology transfer is very much active in India. Many agencies are

involved in TOT to regulate it to ensure effective and safe transfer within the legal

framework. The agencies involved are APCTT, NRDC, TIFAC, BCIL, TBSE, SIDBI.

6.4.1 APCTT

 

It is Asian and Pacific Centre for Transfer of Technology works under United Nations

ESCAP (Economics and Social Commission for Asia and Pacific). The Asian and Pacific

Centre for Transfer of Technology, established on 16 July 1977. The Centre was

established in 1977 in Bangalore, India. In 1993, the Centre moved to New Delhi, India.

It was established under Economic and Social Commission for Asia and the Pacific

resolutions 159 (XXXI) of 6th March 1975 and 164 (XXXII) of 31st March 1976. The

membership of APCTT is identical to the membership of the Economic and Social

Commission for Asia and the Pacific. APCTT has the status of a subsidiary body of

ESCAP.

 Headquarter of APCTT, C-2, Qutab Institutional Area, New Delhi. The current

head of APCTT is Michiko Enomotov

92 Industrial Pharmacy II

Objectives

The objectives of the centre are:

i. To assist the members and associate members of ESCAP through strengthening

their capabilities to develop and manage national innovation systems;

ii. To develop, transfer, adapt and apply technology;

iii. To improve the terms of transfer of technology;

iv. To identify and promote the development and transfer of technologies relevant

to the region.

Governance

i. The centre shall have a governing council (hereinafter referred to as “the council”),

a Director and staff. The centre is located in New Delhi. The centre’s activities

shall be in line with relevant policy decisions adopted by the general assembly,

the economic and social council and the commission. The centre shall be subject

to the financial and staff regulations and rules of the United Nations and the

applicable administrative instructions.

ii. The centre shall have a governing council consisting of a representative designated

by the government of India and no fewer than eight representatives nominated

by other members and associate members of ESCAP elected by the commission.

 

Fig. 6.1: The authorities and agencies involved in TOT

88 Industrial Pharmacy II

Government authorities and agencies involved in TOT (Table 6.2)

Table 6.2: Describing government agencies and their functions in TOT process

Name of agency/authority Functions

Government regulatory authority Issue guidelines

(central as well as state) Regulatory inspections

Monitoring of clinical trials

Quality, efficacy, safety checking of technology

WIPO Protect intellectual property rights of both the parties

Contd.

Table 6.1: Describing functions of departments involved in TOT process

Department Functions

R&D i. Supports technical issues

ii. Resolves technical problems

iii. It would direct and train the production trial at RU.

QA i. Review documentation to check compliance with market authorisation

ii. Compile SUs documents for transfer

iii. Initiates, confirm and compare regulatory requirements of both SUs

and RUs to point out if any change is needed.

QC i. Review analytical requirement and ensure availability with instruments

ii. Mainly responsible for analytical method transfer of product.

Engineering It will review:

i. Equipment requirement

ii. Preventive maintenance and calibration impact.

It will initiate:

i. Engineering modifications

ii. Change or part purchasing

Production i. Review process instructions

ii. It will consider if there is any:

a. Safety implications

b. Impact on local SOPs

c. Training requirement of staff of both SU and RU.

Regulatory affairs i. Coordination of regulatory filing

ii. Response to regulatory inquiries

iii. Ensure the compliance with regulatory guidelines

iv. Ensure compliance with guidelines in case of any variation/change

v. Advise on timing and filing document contents

The material i. Strategic planning

management ii. Resource allocation

iii. Supply chain activities

iv. Recommends most favourable manufacturing strategy by keeping

partnership, internal capability and tax saving in consideration

The project i. Overall coordination among departments

management ii. Allocation of responsibilities to other staffs

iii. Communicate with the management

iv. Designate any other role as appropriate

Regulation of Transfer of Technology 89

6.2 PROBLEMS FACED DURING COMMERCIALISATION

Problems faced per the stages of commercialisation/TOT:

1. Problems during the technology justification and selection stage:

i. Wrong selection of technology.

ii. Cost of buying, installing, maintenance and operation is high.

iii. The technology selected is complex for understanding and implementation.

iv. Technology is not adapted to local conditions and needs extensive adaptations.

2. Problems during the planning stage:

i. SU does not fully understand RU’s need.

ii. RU’s manager is not involved in transfer planning.

iii. Less or no attention is given to software or intellectual needs.

iv. Market forecasting is wrong.

v. The objectives of RU and SU are not clear.

vi. The mechanism chosen for the implementation of technology at RU is not

appropriate.

 

3. Problems during negotiations:

i. Difference between RU and SU approaches and strategies related to negotiation.

ii. Lack of trust between RU and SU.

iii. Difficulty in reaching agreements on IP rights and price of technology.

iv. The unrealistic approach of both RU and SU to reach results in a short time period.

4. Problems during technology implementation:

i. Lack of resources such as: Technical staff, equipment, supporting staff, premises

and equipment, financial resources.

ii. Inability to achieve targets.

iii. Lack of funds and cost-overrun due to poor implementation.

iv. Delay or mismanagement of demand and supply chain.

v. High cost or poor quality of locally available material needed for the

implementation of technology.

5. Miscellaneous

i. Local producers are not able to face international challenges.

ii. Lack of skilled labour on the part of one or both parties.

iii. Incomplete process validation.

iv. The high rate of batch rejection.

v. Not fulfilment of demand for supporting staff or labour.

vi. Incomplete or no documentation.

Table 6.2: Describing government agencies and their functions in TOT process (Contd.)

Name of agency/authority Functions

WTO Set trade rule (like excise duty)

Monitor import and export of technology within countries

ICH Issues guidelines related to qualification, validation, clinical

trials, production, quality control, risk management

WHO Issues guidelines related to technology transfer

Tax department Charges tax/duty based on the type of technology (goods

or services)

90 Industrial Pharmacy II

vii. The product does not show specification or up to the limits as expected or

mentioned by SU.

viii. Delay or no regulatory approval of the product.

The success of technology transfer depends upon 5 Cs (Fig 6.2):

i. Communication

ii. Capacity

iii. Co-ordination

iv. Commitment

v. Co-operation

 

Objective Type Questions

1. WHO guidelines for technology transfer are mentioned in which annexure of

WHO technical report series 961,2011.

a. Annexure 9 b. Annexure 7

c. Annexure 5 d. Annexure 4

2. A logical procedure that control the transfer of any process together with its

documentation and professional expertise between development and manufacture

or between manufacture sites is known as:

a. Technology transfer b. Technology development

c. Process modification d. None of the above

3. Which of the following is a characteristic of ToT as per WHO:

a. It is systematic process

b. It involves transfer of documents

c. It involves transfer of knowledge gained through development process

d. All of the above

4. The unit from where a designated product, process or method is expected to be

transferred is known as:

a. Sending unit b. Receiving unit

c. Processing unit d. None

5. Action of proving and documenting that any process procedure or method actually

and consistently leads to the expected results is known as:

a. Validation b. Qualification

c. Installation d. None of the above

86 Industrial Pharmacy II

6. Assessment of risk and controlling of risk are the steps under:

a. Quality risk management b. Quality control

c. Quality assurance d. Validation

7. Arrange the following with respect to their order of occurrence in QRH process:

1. Risk assessment 2. Risk review 3. Risk control

a. 1, 3, 2 b. 1, 2, 3

c. 3, 2, 1 d. 2, 3, 1

8. Risk reduction is a part of:

a. Risk evaluation b. Risk assessment

c. Risk control d. Risk review

9. Which ICH guidelines explain the process of QRM?

a. Q9 b. Q10

c. Q2 d. Q1

10. FTA stands for:

a. Flowchart technical analysis b. Frequent technical analysis

c. Fault tree analysis d. None of the above

11. In which of the following, the vendor has to transfer analytical method to QC:

a. If drug product is pharmacopoeial

b. If drug product is non-pharmacopoeial

c. If drug substance is pharmacopoeial

d. None

12. Match the following:

 

Terminology Belongs to

a. TOT i. QRM tool

b. HACCP ii. Documentation

c. Risk control iii. Open and closed part

d. FMEA iv. Risk acceptance

e. DMF v. Critical control point determination

13. Fill in the blanks

a. “What can be done to reduce or climate risk?” is answered by ___________.

b. __________ ICH guidelines deal with QRM.

c. ___________ QRM tool is based on the assumption that events are caused due to

deviation in design.

d. __________ is a critical step that ensures RU capabilities to produce and test the

same product as by SU.

e. AMT will be started by ___________ department.

f. AMTP stands for __________

ANSWERS

1. b 2. a 3. d 4. a 5. b 6. a 7. a 8. c

9. a 10. c 11. b 12. a (ii), b(v), c(iv), d(i), e(iii)

13. (a) Risk control (b) Q9 (c) HAZOP (d) AMT (e) Analytical (f) Analytical Method

Transfer Protocol.

Regulation of Transfer of Technology 87

6.1 AUTHORITIES AND AGENCIES INVOLVED IN TOT

The main concern of authorities and agencies involved in TOT is to ensure transfer of

efficient, quality, and safe technology. Government, as well as private (belongs to SU

or RU) agencies, and authorities are involved in TOT (Fig. 6.1)

TT team: As we know that technology transfer is a multidisciplinary approach which

involves representatives and individuals from different departments (Table 6.1) like

i. R&D

ii. QA

iii. QC

iv. Production

v. Engineering

vi. Regulatory affairs

vii. The material management

viii. The project management

87

Regulation of Transfer of

Technology

6

 

Terminology Belongs to

a. TOT i. QRM tool

b. HACCP ii. Documentation

c. Risk control iii. Open and closed part

d. FMEA iv. Risk acceptance

e. DMF v. Critical control point determination

13. Fill in the blanks

a. “What can be done to reduce or climate risk?” is answered by ___________.

b. __________ ICH guidelines deal with QRM.

c. ___________ QRM tool is based on the assumption that events are caused due to

deviation in design.

d. __________ is a critical step that ensures RU capabilities to produce and test the

same product as by SU.

e. AMT will be started by ___________ department.

f. AMTP stands for __________

ANSWERS

1. b 2. a 3. d 4. a 5. b 6. a 7. a 8. c

9. a 10. c 11. b 12. a (ii), b(v), c(iv), d(i), e(iii)

13. (a) Risk control (b) Q9 (c) HAZOP (d) AMT (e) Analytical (f) Analytical Method

Transfer Protocol.

Regulation of Transfer of Technology 87

6.1 AUTHORITIES AND AGENCIES INVOLVED IN TOT

The main concern of authorities and agencies involved in TOT is to ensure transfer of

efficient, quality, and safe technology. Government, as well as private (belongs to SU

or RU) agencies, and authorities are involved in TOT (Fig. 6.1)

TT team: As we know that technology transfer is a multidisciplinary approach which

involves representatives and individuals from different departments (Table 6.1) like

i. R&D

ii. QA

iii. QC

iv. Production

v. Engineering

vi. Regulatory affairs

vii. The material management

viii. The project management

87

Regulation of Transfer of

Technology

6