Questions and Answers
What is technology transfer defined as in the context of industrial pharmacy?
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.
What are the three main units involved in the technology transfer process?
The sending unit (SU), the receiving unit (RU), and the unit managing the process.
What is one of the barriers to technology transfer due to inadequate resources?
Inadequate funding.
What is an essential aspect of practical technology transfer according to researchers' mindset?
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What is the purpose of WHO guidelines for technology transfer?
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What is a common fear associated with technology transfer?
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What is the importance of a documented and planned approach in technology transfer?
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What is a key aspect of technology transfer in terms of quality control?
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What is the basis of Good Manufacturing Practice (GMP) according to current regulatory guidance?
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What is the primary purpose of risk management in technology transfer?
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What is technology transfer in the context of pharmaceutical manufacturing?
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What are the three main parts of a typical technology transfer process?
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What is the major consequence of comparability risk in technology transfer?
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Why is cleaning a crucial parameter in a pharmaceutical manufacturing plant?
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What type of changes require continuous assessment in technology transfer?
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What type of information should the SU provide to the RU to define a cleaning strategy?
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What is the key feature of an integrated technology transfer team structure?
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What is the name of the approach used to assess and mitigate risks in technology transfer?
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Who is responsible for developing the product transfer protocol?
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Why is it important to consider the technical expertise of staff and the capabilities of the manufacturing site during technology transfer?
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What skills are essential for reducing project risks in technology transfer?
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What is the primary goal of a cleaning procedure in a pharmaceutical manufacturing plant?
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What is the consequence of manufacturing process risks in technology transfer?
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Where is FITT located?
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What was the outcome of the Technology Vision 2020 exercise?
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Who is the nodal ministry for Biotech Consortium India Limited (BCIL)?
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What is the purpose of a change control log in pharmaceutical manufacturing?
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What is the full form of BIPP?
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What is the address of SIDBI?
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What is the main objective of SIDBI?
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Why is goal-oriented behavior important in technology transfer?
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What is FITT?
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What type of information is typically included in scale-up activities?
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What is the primary function of Biotech Consortium India Limited (BCIL)?
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What type of information is typically included in a facility description?
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What is the purpose of process maps, flow charts, and master batch records?
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What type of information is typically included in a description of analytical methods?
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What is the purpose of annual product quality reviews?
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What type of information is typically included in a pilot report?
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What is the purpose of deviation and change control reports?
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Study Notes
Technology Development and Transfer
- Technology transfer is a logical procedure that controls the transfer of a process, including its documentation and professional expertise, between development and manufacture or between manufacture sites.
- It requires a documented, planned approach, trained and knowledgeable personnel, and a compliant quality system.
- The process involves a sending unit (SU), a receiving unit (RU), and a unit managing the process.
Barriers to Technology Transfer
- Lack of awareness, knowledge, and efficiency
- Lack of government focus and low market share
- Web access and scientific publications
- Cost of prequalification
- National security issues and restrictions
- Inadequate funding and possible treaties
- Labour issues
Practical Aspects of Technology Transfer
- Mindset of researchers
- Implementation of policies
- Lack of platforms and disconnect from markets
- Project type
- Finding and retaining expertise
- Finding resources
- Clarity and transparency
- Fear of technology risk
- Ecosystem promoting tech innovation
- Institutional mechanisms
- Research ideas
WHO Guidelines for Technology Transfer
- Guiding principles provide a flexible framework for guidance
- Risk management is an integral part of technology transfer
- Table 1 lists types of risks associated with technology transfer, including:
- Comparability
- Manufacturing process
- Equipment, utilities, and facility
- Project
Systematic Process for Quality Risk Management (QRM)
-
- Types of changes:
- Known changes
- Unanticipated changes
-
- Risk Management Structure and Organization:
- Critical aspect of risk management
- Integrated technology transfer team structure
-
- Risk Assessment and Mitigation Approach (RAMA):
- Part of company DNA
- Application in all technology transfers and project lifecycle
- Managed by flexible, robust, and efficient tools
Transfer from R&D to Production
- Technology transfer:
- Process by which manufacturing process, packaging, and cleaning, and analytical methods are transferred from one manufacturing unit to another or from R&D to manufacturing unit
- Typical technology transfer process involves:
- Production part (including packaging)
- Quality control part (including analytical methods)
- Documentation part
- RU and SU develop product transfer protocol jointly to transfer product-related information
Cleaning
- Critical parameter in technology transfer
- Minimizes risk of contamination, cross-contamination, operator exposure, and environmental effects
- SU provides information related to cleaning at SU to minimize cross-contamination
Additional Information
- Information on scale-up activities
- Information on full-scale development activities
- Change history and reasons
- Investigations of critical issues and problems
Other Organizations
- Biotech Consortium India Limited (BCIL):
- Promoted by Department of Biotechnology (DBT), Government of India
- Financed by All India Financial Institutions (AIFI) and corporate sectors
- Major functions include development and transfer of technology for commercialization of biotechnology products
- The Technology Bureau for Small Enterprises (TBSE) / Small Industries Development Bank of India (SIDBI):
- Acts as the principal financial institution for promotion, financing, and development of MSME sector
- Foundation for Innovation and Technology Transfer (FITT):
- Industrial interface organization established at Indian Institute of Technology Delhi (IIT Delhi) as a Registered Society
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Description
This quiz covers the introduction to technology development and transfer in industrial pharmacy, including the definition and requirements of technology transfer.