WHO GUIDELINES FOR TECH.TRANSFER SIDHANTA SAHU.

WHO guidelines for tech. transfer ,by sid.
introduction of tech. transfer
WHO
scope of WHO
TOT

1. WHO GUIDELINES FOR TECHNOLOGY TRANSFER NAME:-SIDHANTA SAHU CLASS:- B.PHARMA 7 TH SEM REGD NO:- 1803268086 SUB:-INDUSTRIAL PHARMACY-II 1

2. CONTENTS Introduction of Technology Transfer WHO guidelines for Technology Transfer Scope of WHO Guidelines Why / Reasons of TOT Reference 2

3. TECHNOLOGY TRANSFER It is defined as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development & manufacture or between manufacture sites.” It is both integral & critical to the drug discovery & development process for new medicinal products. 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. 3

4. LIFE CYCLE OF TECHNOLOGY TRANSFER PROCESS 4

5. WHO GUIDELINES FOR TECHNOLOGY TRANSFER WHO Guidelines for technology transfer are the guiding principles that provides flexible frame work as guidance. The major intention behind this guidelines is to place special attention on the quality aspects of a pharmaceutical products. The pharmaceutical companies involve intra & inter company transfer of technology for need of additional capacity, relocation of operations & merges etc. 5

6. TOT requires a documented & planned approach. It involves transfer of documentation as well as the ability of Sending unit(SU) & Receiving unit(RU). To have a successful transfer, the project planned should encompass & must be based upon the principle of Quality Risk Management(QRM).

7. 7 TOT could be successful only if there is documented evidence to prove RU routinely reproduces the transferred product. If RU identifies any problem with process during transfer, unit should communicate to SU to ensure knowledge updates. Intellectual Property Rights(IPR), this issue may create impact on open communication about technical matters .

8. SCOPE OF WHO GUIDELINES WHO guidelines for TOT provides guidance transfer of QC methods. GENERAL RECOMMENDATIONS:- It specify guidance in principle & provides for the activities necessary to conduct a successful intra & inter site TOT. GUIDELINES FOR MATERIALS:- It can be applied to manufacturing of Active Pharmaceutical Ingredients(API), packaging of bulk materials. 8

9. 9 GUIDELINES FOR SPECIFIC PRODUCTS:- It may be applied to all dosage forms and adjusted for specific dosage forms. GUIDELINES FOR SU & RU:-It includes Transfer of development and production. Transfer of analytical methods for QC & QA. Skills assessment & training of personal. Organization & management of transfer. Assessment of premises & equipment. Documentation, Qualification & Validation.

10. WHY /REASONS OF TOT Lack of Manufacturing capacity. Lack of resources to launch product commercially. Lack of Marketing distribution & capability. Forming alliance with partners Forming alliances with manufacturing capability 10

11. REFERENCE REFERED BY NIRALI PUBLICATION AUTHOR:- Dr. ASHOK A . HAJARE 11

12. THANK YOU 12