This document provides information about technology transfer in the pharmaceutical industry. It defines technology transfer as the logical procedure that controls the transfer of any process along with documentation and expertise between development and manufacturing sites. The WHO guidelines for technology transfer provide a flexible framework to guide the transfer process with a focus on quality. The scope of the WHO guidelines includes guidance for transferring manufacturing processes of APIs, packaging, and all dosage forms. Reasons for technology transfer include a lack of manufacturing capacity, resources, or marketing capabilities.

1. NAME:-SIDHANTA SAHU
CLASS:- B.PHARMA 7TH SEM
REGD NO:- 1803268086
SUB:-INDUSTRIAL PHARMACY-II
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2. CONTENTS
Introduction of Technology Transfer
WHO guidelines for Technology Transfer
 Scope of WHO Guidelines
Why / Reasons of TOT
Reference
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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.
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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.
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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).

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 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.
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 GUIDELINES FOR SPECIFIC 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.

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
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11. REFERENCE
REFERED BY NIRALI PUBLICATION
AUTHOR:- Dr. ASHOK A . HAJARE
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12. THANK YOU
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