WHO GUIDELINES FOR TECH.TRANSFER SIDHANTA SAHU.

WHO GUIDELINES FOR TECH.TRANSFER SIDHANTA SAHU.

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  NAME:-SIDHANTA SAHU CLASS:- B.PHARMA7TH SEM REGD NO:- 1803268086 SUB:-INDUSTRIAL PHARMACY-II 1
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  CONTENTS Introduction of TechnologyTransfer WHO guidelines for Technology Transfer  Scope of WHO Guidelines Why / Reasons of TOT Reference 2
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  TECHNOLOGY TRANSFER It isdefined 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
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  LIFE CYCLE OFTECHNOLOGY TRANSFER PROCESS 4
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  WHO GUIDELINES FORTECHNOLOGY 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
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   TOT requiresa 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).
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  7  TOT couldbe 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 .
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  SCOPE OF WHOGUIDELINES 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
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  9  GUIDELINES FORSPECIFIC PRODUCTS:- It may be applied to all dosage forms and adjusted for specific dosage forms.  GUIDELINES FOR SU & RU:-It includes a) Transfer of development and production. b) Transfer of analytical methods for QC & QA. c) Skills assessment & training of personal. d) Organization & management of transfer. e) Assessment of premises & equipment. f) Documentation, Qualification & Validation.
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  WHY /REASONS OFTOT 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
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  REFERENCE REFERED BY NIRALIPUBLICATION AUTHOR:- Dr. ASHOK A . HAJARE 11
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  THANK YOU 12