Vol 5, Issue 1, 2023 (357-367)
http://journal.unpad.ac.id/idjp
*Corresponding author,
e-mail : shofiah17001@mail.unpad.ac.id (S. Sumayyah)
https://doi.org/10.24198/idjp.v5i1.40867
© 2023 S. Sumayyah et al
Review: Management Technology Transfer in the Indonesian Pharmaceutical Industry
Shofiah Sumayyah*,1, Adila Resca Harda2, Norisca Aliza Putriana3
1Pharmacy Professional Program, Faculty of Pharmacy, Padjajaran University
2Department of Pharmaceutical and Formulation Technology, Faculty of Pharmacy,
Padjajaran University
Submitted : 24/07/2022, Revised : 13/08/2022, Accepted : 16/01/2023, Published : 08/01/2023
Abstract
This review article focuses on technology transfer in the pharmaceutical industry,
specifically discussing its importance, guidelines, process, and documentation in the
Indonesian context. The purpose is to provide a detailed understanding of technology
transfer from drug discovery to product development, including the reasons for its
utilization and its significance in the pharmaceutical sector. The methodology
employed for this review involved searching online literature through platforms such
as ScienceDirect and Google Scholar using keywords like "Transfer Technology"
and "Pharmaceutical Development." The findings of the primary sources emphasize
the crucial role of technology transfer in facilitating the growth of the pharmaceutical
industry. It enables the availability of essential technologies in developing countries,
promoting accessibility and affordability. Three key factors contribute to effective
technology transfer: proper planning, involvement of capable individuals, and a well-
defined process. Success in technology transfer necessitates a comprehensive
understanding of the process and the ability to predict its future performance
accurately. Furthermore, the article emphasizes the importance of ensuring robust
and effective manufacturing processes for drug substances and drug products. This
includes producing these substances and products in compliance with registered
specifications and adhering to Good Manufacturing Practices
Keywords: Transfer technology, Pharmaceutical development, Research and
development, Pharmaceutical industry.
S. Sumayyah et al / Indo J Pharm 5 (2023) 357-367
358
1. Introduction
The Industrial Revolution 4.0 is an
era of industrialization which is currently the
direction of goals for the development and
development of the world's industrial and
manufacturing sectors. Currently, countries
in the world are starting to compete in the use
of technology in each of their industrial
sectors [1]. Indonesia is in the class of nascent
countries which shows a weak production
structure and economic structure [2]
Therefore, the government in Indonesia has
designed Making Indonesia 4.0 as an
integrated roadmap to implement several
strategies in entering the Industry 4.0 era. [3]
Industries, in general, are not born
with characteristics of Industry 4.0. They go
through an evolutionary process, adopting
new technologies from their own
headquarters, subsidiaries, suppliers, and/or
even through TT industry models. Thus, for
an industry to be considered fit to accompany
the 4.0 Industrial Revolution, Technology
Transfer will be necessary in one way or
another to meet the needs of an increasingly
competitive market [4].
According to WHO (TRS 961,
Appendix 7), technology transfer is “a
systematic procedure followed to impart the
knowledge and documented experience
acquired during development and/or
commercialization to appropriate,
responsible, and authorized parties.” Through
this process, the donor site (either product
sponsor or manufacturing site) transmits
proprietary knowledge and experience about
a product, related manufacturing processes,
and/or relevant analytical methods to the
recipient manufacturing site. This allows the
receiving site to perform the activities
necessary to produce the product at a scale
suitable for the development stage [5]. In
some cases, it can involve transfers to
different facilities in different regions and
countries [6] In the technology transfer
process it is important to ensure that product
quality and performance built during R&D do
not change if produced in full-scale
commercialization. Therefore, management
technology transfer usually involves several
functional areas, such as pharmaceutical and
analytical R & D, quality of operations,
regulatory affairs, and program management
[7].
2. Method
The preparation of the article review
was carried out by searching literature from
primary and secondary sources, namely
regulations and standards of authority
institutions in Indonesia, academic journals,
and reference books related to Technology
Transfer. Primary sources were obtained
from journals, which were then screened
against journals published in the last 10 years
as criteria. Literature obtained online in
various international and national journals
accessed from Google Scholar and
ScienceDirect sites with the keywords
"Transfer Technology" and "Pharmaceutical
Development". Articles are displayed with
the keyword in the database ScienceDirect
shows the results of 3 articles and Google
Scholar 35 [21 inclusion, 14 exclusion (50
years)].
S. Sumayyah et al / Indo J Pharm 5 (2023) 357-367
359
Table 1. Methods performed for review
3. Result and Discussion
3.1 Reason for Using Technology
Transfer
In general, the reasons for technology
transfer include: [6]
a. Due to lack of production capacity: -
The source site may only have
manufacturing equipment suitable for
small-scale operations and must
collaborate with other organizations or
companies to carry out large-scale
manufacturing.
b. Due to the lack of marketing
distribution and distribution
capabilities
c. Due to a lack of resources to launch the
product commercially
d. Verify the creation process between
one site and another.
For developing countries like Indonesia,
technology is needed to support the success
of national development. Limited human
resources, budget for education, research, and
development as well as the capacity to master
technology which is still relatively low means
that Indonesia does not have to invent or
produce its technological inventions, but it
will be more efficient to transfer technology
from other countries that have advanced
technology through investment activities.
investment) from these countries [8]
3.2 Guidelines/Importance of
Technology Transfer
In ICH Q8(R2), companies have the option to
improve product quality by evaluating
innovative approaches across product
lifestyles. For example, recipient sites may
view the program in a new light and may
determine that new and more appropriate
equipment/technology will streamline
manufacturing processes [9]. Technology
transfer activities aim to transfer product and
process knowledge between development
(Receiving site) and manufacturing (Source
site) to achieve product realization. This
knowledge forms the basis for manufacturing
processes, control strategies, process
validation approaches, and continuous
improvement. Technology transfer offers the
opportunity to evaluate and redesign or
modernize various elements of a company's
analytical methods or manufacturing
processes [10].
The technology transferred is in the form
of:
•Production process and packaging
process
Articles from the database: 38 articles
Inclusion (n=21)
Exclusion (n=14)
--- Published date is over 20 years (n=14)
S. Sumayyah et al / Indo J Pharm 5 (2023) 357-367
360
•Analysis methods (raw material analysis,
IPC, release requirements analysis, and
stability study requirements analysis)
In its implementation, it must refer to the
instructions and procedures that have
been informed by R&D at the source site
for the smooth production of commercial
products to produce medicinal products
that are efficacious, quality, and safe
following registered specifications and
requirements for Good Manufacturing
Practices [11].
The general impact of technology
transfer project: [12]
a. Improvement of research
pertinence and its promotion in
foreign countries
b. Contribution to the creation and
consolidation of research groups
and centers for technology
development, involving the
training of young research
students.
c. Promote interdisciplinary
projects to be developed in the
region of interest.
3.3 Technology Transfer Process and
Policy
There are two sorts of technology
transfer processes: [13]
a. Vertical
Vertical technology transfer
refers to the transfer of data from
basic study to development and
production respectively.
b. Horizontal
Horizontal technology transfer refers to the
movement and application of technology to
be used in one place or context to a different
place.
Commercial technology transfer is
mutually agreed upon, and the goal is
destined. The achievement of any specific
technology transfer depends upon method
understanding or the flexibility to predict
exactly the long-term performance of a
process [14].
To ensure the safety, efficacy, and
quality of the products produced during the
technology transfer process, it is necessary to
apply the quality assessment standards set by
the local health authority that regulates drug
regulation and control in each region
(Receiving site). Formalizing the technology
transfer policy can be expected: [15]
•Positive impact on product quality
•Facilitate the introduction of new
products in the market
•Compliance with regulatory
requirements guaranteed
•Costs reduced
3.4 Step in Technology Transfer
1. Technology Transfer Models
One of the proposed models for effective
technology transfer is The Chantramonklasri
Model [16], who proposes a five phases
model as shown in Figure 1
S. Sumayyah et al / Indo J Pharm 5 (2023) 357-367
361
Figure 1 The Five-phase Model of international technology transfer [17]
The five phases of this model are as follows
[16]:
•Carrying out a pre-investment and
feasibility study
•Developing engineering specifications
and design based on the feasibility study
•Commence capital goods production
based on the engineering specifications
and designs that have been developed.
•Commissioning and start-u including
comprehensive of the workforce
•Commence commercial production
2. Step in Technology Transfer
Technology transfer can be carried
out by considering environmental
conditions, facilities, availability of active
substances, and excipients between the
Source Site and Receiving Site to ensure the
quality of the resulting product [18].
The stages in the technology transfer
process are generally classified into three
categories, namely: [19, 20, 21]
1. Technology development by RnD
(Research Stage)
•Procedure design and selection of
excipients
•Identification of specifications and
quality
The quality of the products developed must
meet the product specifications of the
innovator.
S. Sumayyah et al / Indo J Pharm 5 (2023) 357-367
362
2. Technology transfer from RnD to
production (Development Stage) R&D
prepares Technology Transfer
documents to the Receiving Site which
contain all related information:
•Master formula card (MFC)
•Master Packaging Card (MPC)
•Master Formula
•Standard Test Procedures Specifications
•Development report
•Packaging development report
In the development stage, several things need
to be considered, including:
•Research for factory production
To produce drugs with quality according
to the design, it is necessary to determine the
appropriate quality control methods and
manufacturing methods so that stable quality
can be guaranteed to realize the production of
drugs designed based on the results of small-
scale experiments.
•Consistency between quality and
specifications
Verification is necessary to ensure that
the specifications that have been set are
adequate. Consistency between quality and
specifications is to ensure in product
specifications that the quality specified in
the design is guaranteed quality because the
quality of manufacture and product meets
design quality.
•Assurance of consistency through
development and manufacturing
To make the developed product have
indications as predetermined in clinical
phases, the quality of design should be
reproducible as the quality of the product
(assurance of consistency). The source site is
fully responsible for the technical
information required by the Receiving Site to
realize the actual manufacturing formula and
production facilities, while the Receiving site
is responsible for the manufacture and
determination of evaluation methods to
determine whether the drug to be produced
meets the design quality. The technical
information to be transferred must be
compiled as an R&D report.
3. Optimization and Production
(Production Stage)
•Selection of method
The method used in the production
stage is selected based on the data provided
from R&D. The stages in the process of
granulation, mixing, compression and
coating are important parameters for
technology transfer. The standards and
evaluation methods that have been previously
established at the development stage are not
always adequate for the scale of production,
so feedback and collecting technical
information obtained from iterative
production processes are needed. In addition,
it is important to appropriately modify the
various pre-defined standards.
•Validation Study
The method used in the production
process must carry out a validation study
which shows that the process can produce a
stable product based on the formula from the
source site. The research and development
department is responsible for carrying out
validations such as performance
qualification, cleaning validation, and
process validation for the product/drug to be
transferred.
•Considerations of different parameters
for scale-up Flexibility, Cost,
Dependability, Innovation, and Product
Quality must be considered before
starting the scale-up process at the
S. Sumayyah et al / Indo J Pharm 5 (2023) 357-367
363
Receiving Site to achieve success in
technology transfer.
•Scale-up
Scale-up followed after getting all
information from R&D. It involved the
transfer of technology and the transfer of
knowledge. From sifting to film coating each
process had its own set of challenges. The
development of robust formulation and
process through the use of Design of
Experiments (DoE) as well as understanding
the critical v/s non-critical parameters for
each operation were major determining
factors for success v/s failure on scale-up.
Full-scale commercialization includes Active
Pharmaceutical Ingredients (API), Drug
products (dosage form or delivery system),
and analytical methods.
Figure 2 Flow chart of technology transfer in pharmaceutical industry [17]
*Corresponding author,
e-mail : shofiah17001@mail.unpad.ac.id (S. Sumayyah)
https://doi.org/10.24198/idjp.v5i1.40867
© 2023 S. Sumayyah et al
3.5 Implementation and
Documentation of Technology
Transfer [16, 22]
1. Preparation for Technology
Transfer
•Pre-transfer Assessment
In the pre-transfer assessment stage,
several important documents related to
technology transfer are reviewed and
examined. Based on the results of the
review, the technology transfer team will
conduct a high-level gap analysis to
determine feasibility.
After the feasibility assessment is
carried out, the supply model is determined
and other Pre-transfer activities are
completed, the completion of the Pre-
transfer phase must be approved by the
Sponsor/Steering committee for a decision
to proceed with the technology transfer
project.
•Technology Transfer
Organization
Determination of a Technology
Transfer Leader and formation of a
Technology Transfer Team consisting of
several qualified people from the Source
Site and Receiving Site. To initiate and
document technology transfer, the CCP
(Change Control Proposal) must be
prepared by the Technology Transfer
Leader in the Receiving Site quality
system. At the technology transfer
preparation stage, a kick-off
meeting was held to hold a
meeting between the technology
transfer team and plan for the
preparation of the Technology
Transfer Master Plan (TTMP)
and other documents.
2. Implementation of Technology
Transfer
•Preparation of Technology
Transfer Master Plan (TTMP)
and Technology Transfer Master
Report (TTMR)
The TTMP is prepared by the TT
Leader together with the TT Team before
the kick-off meeting and if there are
changes to the original plan or important
aspects of the project, the TTMP must be
updated during the technology transfer
project. The protocol should include: [5]
1. Objective;
2. Scope;
3. Key personnel and their
responsibilities;
4. A parallel comparison of materials,
methods, and equipment;
5. The transfer stages with documented
evidence that each critical stage has
been satisfactorily accomplished
before the next commences;
6. Identification of critical control points;
7. Experimental design and acceptance
criteria for analytical methods;
8. Information on trial production
batches, qualification batches, and
process validation;
9. Change control for any process
deviations encountered;
10. Assessment of end-product;
11. Arrangements for keeping retention
samples of active ingredients,
intermediates, and finished products,
and information on reference
substances where applicable; and
12. Conclusion, including signed-off
approval by the project manager.
After the technology transfer success
criteria are met, the TTRM can be prepared
by referring to the documents used during
the technology transfer
•Project Risk Assessment
Risk Assessment is carried out by
the technology transfer team to identify
risks that might interfere with the
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365
technology transfer. Mitigation of risks
must be identified, planned, and
implemented. Assessment may include
(but is not limited to) the following:
- Equipment and area
- Scale
- Availability of documents
- Development history
The Risk Assessment document
should be updated as new information
becomes available.
•Gap Analysis/Process Risk
Assessment
Conducted to identify gaps in
the existing processes or methods at
the Source Site and Receiving Site.
This gap must be assessed whether it
is acceptable or mitigated. The Gap
Analysis document should be
updated as new information becomes
available
•Preparation of technology transfer
protocols and reports
Protocols and reports are
made separately for each activity
and then checked and approved
by both sites.
•Implementation of Training
3. Manufacturing Process
4. Finalization of the technology
transfer project
Technology transfer can be finalized
when the success criteria have been met,
and the technology transfer report and
validation report have been approved.
TTMR began to be compiled, checked,
and approved by both sites. The TT
Leader must ensure that the final version
of the technology transfer document is
available on the Change Control Record
and confirm the completion of the
technology transfer activity.
3.6 The Success of Technology
Transfer
Successful technology transfer
depends on many factors, including the
ability to anticipate future risks, so it
requires a team that is prepared to deal with
any eventuality, including the unexpected.
It is important to connect the dots across the
various elements of launch readiness (e.g.,
machines, manpower, materials,
manufacturability, measurement, market,
and mitigation) through the utilization of a
comprehensive risk management process
[23]. A successful technology transfer
should always be documented. There
must be evidence that the receiving site
can routinely reproduce the transferred
product, process, or method against a
predetermined set of acceptance criteria as
described in the technology transfer plan,
and such evidence must be created with
reference to the Quality Target Product
Profile (QTPP) and Critical Quality
Attributes (CQA) of the product.
Comparability assessment is usually
carried out to confirm the successful
completion of technology transfer [5, 24]
4. Conclusion
In the pharmaceutical industry,
technology transfer is very important for
better company growth and useful for
making technologies available to people in
developing countries easily and
economically (including Indonesia)
Appropriate efficiency in technology
transfer from development to
commercialization can be achieved through
better communication and documentation
by the technology transfer team. The
technology transfer does not mean one-time
actions taken by Souce Site toward
Receiving Site but means continuous
information exchange between both the
Site to maintain the product manufacturing.
To assure drug quality, it is desirable to
make sure that is what, when, and why the
information should be transferred to where
and by whom, and how to transfer, then
S. Sumayyah et al / Indo J Pharm 5 (2023) 357-367
366
share knowledge and information of the
technology transfer each other between
stakeholders related to drug manufacturing.
5. Acknowledgments
The author of this article is grateful
to the lecturer and preceptor in the Working
Practice of the Pharmacy Professional
Program who has been supportive and
helpful in providing data and information
for this study.
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