Industrial Pharmacy 2: Technology Development and Transfer

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?

Clarity and transparency. Signup and view all the answers

What is the purpose of WHO guidelines for technology transfer?

To provide a flexible framework as guidance. Signup and view all the answers

What is a common fear associated with technology transfer?

Fear to technology risk. Signup and view all the answers

What is the importance of a documented and planned approach in technology transfer?

It ensures control of the transfer of processes, documentation, and professional expertise. Signup and view all the answers

What is a key aspect of technology transfer in terms of quality control?

Compliant quality system. Signup and view all the answers

What is the basis of Good Manufacturing Practice (GMP) according to current regulatory guidance?

Scientific principles Signup and view all the answers

What is the primary purpose of risk management in technology transfer?

To reduce risks associated with technology transfer Signup and view all the answers

What is technology transfer in the context of pharmaceutical manufacturing?

The process of transferring manufacturing process, packaging, cleaning and analytical methods from one unit to another or from R&D to manufacturing unit Signup and view all the answers

What are the three main parts of a typical technology transfer process?

Production, quality control, and documentation Signup and view all the answers

What is the major consequence of comparability risk in technology transfer?

Non-comparability of process or product between SU and RU Signup and view all the answers

Why is cleaning a crucial parameter in a pharmaceutical manufacturing plant?

To minimize the risk of contamination, cross-contamination, operator exposure, and environmental effects Signup and view all the answers

What type of changes require continuous assessment in technology transfer?

Unanticipated changes Signup and view all the answers

What type of information should the SU provide to the RU to define a cleaning strategy?

Information on solubility of active ingredients, excipients, and vehicles, minimum therapeutic doses, therapeutic category, and toxicological assessment Signup and view all the answers

What is the key feature of an integrated technology transfer team structure?

Cross-functional teams on a continuous basis Signup and view all the answers

What is the name of the approach used to assess and mitigate risks in technology transfer?

Risk Assessment and Mitigation Approach (RAMA) Signup and view all the answers

Who is responsible for developing the product transfer protocol?

RU and SU jointly Signup and view all the answers

Why is it important to consider the technical expertise of staff and the capabilities of the manufacturing site during technology transfer?

To ensure that the necessary information is transferred effectively and the site can run the transfer process successfully Signup and view all the answers

What skills are essential for reducing project risks in technology transfer?

Technical skills, planning, multitasking, organization flexibility, troubleshooting, and negotiation Signup and view all the answers

What is the primary goal of a cleaning procedure in a pharmaceutical manufacturing plant?

To minimize the risk of contamination, cross-contamination, operator exposure, and environmental effects Signup and view all the answers

What is the consequence of manufacturing process risks in technology transfer?

Risks to routine manufacturing, such as microbial contamination risks and operator error Signup and view all the answers

Where is FITT located?

Indian Institute of Technology Hauzkhas, New Delhi-110016 Signup and view all the answers

What was the outcome of the Technology Vision 2020 exercise?

A set of 17 documents, 16 on technology areas and 1 on services Signup and view all the answers

Who is the nodal ministry for Biotech Consortium India Limited (BCIL)?

Department of Biotechnology (DBT), Ministry of Science and Technology, India Signup and view all the answers

What is the purpose of a change control log in pharmaceutical manufacturing?

To document changes made to the process, primary packaging, and analytical methods as part of process optimization or improvement. Signup and view all the answers

What is the full form of BIPP?

Biotechnology Industry Partnership Programme Signup and view all the answers

What is the address of SIDBI?

SIDBI Tower, 15, Ashok Marg, Lucknow - 226001, Uttar Pradesh Signup and view all the answers

What is the main objective of SIDBI?

Promotion, financing, and development of the Micro, Small and Medium Enterprise (MSME) sector Signup and view all the answers

Why is goal-oriented behavior important in technology transfer?

It helps to reduce project risks by focusing on specific objectives Signup and view all the answers

What is FITT?

Foundation for Innovation and Technology Transfer, an industrial interface organization Signup and view all the answers

What type of information is typically included in scale-up activities?

Process optimization, statistical optimization of critical process parameters, critical quality attributes, pilot report, and information on pilot-scale development activities. Signup and view all the answers

What is the primary function of Biotech Consortium India Limited (BCIL)?

Development and transfer of technology for commercialization of biotechnology products Signup and view all the answers

What type of information is typically included in a facility description?

Validation requirements and equipment, starting materials, material safety data sheets, and storage requirements for raw materials and finished products. Signup and view all the answers

What is the purpose of process maps, flow charts, and master batch records?

To describe manufacturing steps, including qualification of in-process hold times and conditions, order and method of raw material addition, and bulk transfers between processing steps. Signup and view all the answers

What type of information is typically included in a description of analytical methods?

Detailed description of the analytical methods used to test the product. Signup and view all the answers

What is the purpose of annual product quality reviews?

To review and assess the quality of the product and identify areas for improvement. Signup and view all the answers

What type of information is typically included in a pilot report?

Information on pilot-scale development activities, including the number of batches manufactured. Signup and view all the answers

What is the purpose of deviation and change control reports?

To document and justify changes made to the manufacturing process. Signup and view all the answers

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)

1. Types of changes:
- Known changes
- Unanticipated changes
1. Risk Management Structure and Organization:
- Critical aspect of risk management
- Integrated technology transfer team structure
1. 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

Studying That Suits You

Use AI to generate personalized quizzes and flashcards to suit your learning preferences.

Description

This quiz covers the introduction to technology development and transfer in industrial pharmacy, including the definition and requirements of technology transfer.