Description
Technology development and transfer: WHO guidelines for Technology
Transfer(TT): Terminology, Technology transfer protocol, Quality risk management, Transfer from R & D to production (Process, packaging and cleaning), Granularity of TT Process (API, excipients, finished products,
packaging materials) Documentation, Premises and equipments, qualification
and validation, quality control, analytical method transfer, Approved regulatory bodies and agencies, Commercialization – practical aspects and problems (case studies), TT agencies in India – APCTD, NRDC, TIFAC, BCIL, TBSE / SIDBI; TT related documentation – confidentiality agreement, licensing,
MoUs, legal issues
Technology Development and Transfer Who Guideline for Technology Transfer (TT) Different Terminologies of Technology Transfer (TT) General Principles of Technology Transfer (TT) Technology Transfer Protocols Quality Risk Management (QRM) Introduction Principle QRM Process Information Required for Technology Transfer Starting Materials Process Information Finished Products Packaging Documentation Premises Equipments Qualification and Validation Analytical Method Transfer 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) Technology Transfer Related Documents Confidentiality Agreement Licensing MoUs
• Questions
Different terminologies of Technology Transfer (TT)
Basic principles of TT
TT protocols
Information required for TT
Agencies for Technology Transfer in India
2.1 WHO GUIDELINE FOR TECHNOLOGY TRANSFER (TT)
Technology transfer (TT) is a structural guideline which is intended for quality of the process, products, standardization and cost-effective productions. This is a systematic process in which knowledge and experience are gathered and documented during life cycle of products originated from development, manufacturing,
production and marketing or commercialization and are transferred to an authorized and accountable organization. TT is a fundamental part of discovery and development of newer pharmaceutical products and dosage forms. 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, TT is involved in drug discovery, product development, clinical trials and full-scale commercialization.
2.2 DIFFERENT TERMINOLOGIES OF TECHNOLOGY TRANSFER (TT)
1. Active Pharmaceutical Ingredients (API): Any ingredients or substances which are used in the manufacturing of a pharmaceutical formulation and are considered as active ingredient of that dosage forms, are called as Active Pharmaceutical Ingredients (API)
Long-Answer Questions:
1. What is an NDA? Discuss the requirements of data while filing a NDA. Give examples
where a NDA can be filed.
2. Comment on the bioequivalence requirements according to ICH guidelines.
3. Discuss the Intellectual Property protection laws in India in brief.
4. What is PCT? Discuss the content of PCT and its applications.
5. Write a note on Drug Master Files.
6. Briefly discuss Master Formula Record and its importance.
7. What are the elements of a clinical trial? Describe systematically the protocol of a
clinical trial.
8. Write short notes on Pharmacovigilance.
9. Write short notes on Investigator Brochure.
10. Discuss the NDA regulatory approval process with suitable example.
11. Write a note on outsourcing BA-BE studies to CRO.
12. Write short notes on the Post marketing surveillance.
