GUPTA COLLEGE OF TECHNOLOGICAL

SCIENCES
Ashram More, G. T. Road, Asansol-713301, West Bengal
CA – 2 EXAMINATION

TOPIC- WHO GUIDELINES FOR TECHNOLOGY TRANSFER

➢ NAME- SOUMEN KARMAKAR

➢ ROLL. NO- 12401921048
➢ SUBJECT- INDUSTRIAL PHARMACY II
➢ PAPER CODE- PT716A
➢ B.PHARM, 4TH YEAR, 7TH SEM
 CONTENTS

➢ Introduction

➢ Guidelines

➢ Facts of technology transfer

➢ Constituents Technology transfer

➢ Sectors involving technology transfer

➢ Risk Assessment technology transfer

➢ Conclusion

➢ Reference

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Introduction
➢ Technology transfer is a logical procedure that controls the transfer of products, processes
and knowledge together with its documentation and professional expertise. Technology
transfers may involve development, manufacturing and testing sites.
➢ The transfer of production and control procedures of pharmaceutical products from one
site to another may take place before or after obtaining regulatory marketing authorization.
Product transfer may therefore occur during development, full-scale commercialization
and commercial batch manufacturing. The level of rigor applied in the technology transfer
should be commensurate with the respective product life cycle phase.
➢ A technology transfer, particularly one between different companies, has legal and
economic implications which may include intellectual property rights, royalties, pricing,
conflicts of interest and confidentiality agreements. Such matters should therefore be
addressed.
➢ A technology transfer requires a planned approach by trained, knowledgeable personnel
working within a quality system with the appropriate documentation, data and information
covering all aspects of development, production and quality control (QC), as applicable,
and considering the stage of the product life cycle and the regulatory requirements.

Guidelines
➢ Active pharmaceutical ingredient (API). Any substance or mixture of substances
intended to be used in the manufacture of a pharmaceutical dosage form and that, when so
used, becomes an active ingredient of that pharmaceutical dosage form. Such substances
are intended to furnish pharmacological activity or other direct effect in the diagnosis,
cure, mitigation, treatment or prevention of disease, or to affect the structure and function
of the body.
➢ ALCOA+. A commonly used acronym for “attributable, legible, contemporaneous,
original and accurate that puts additional emphasis on the attributes of being complete,
consistent, enduring and available – implicit basic ALCOA principles.
➢ bracketing. An experimental design to test the extremes of, for example, dosage strength.
The design assumes that the extremes will be representative of all the samples between the
extremes.
➢ change control. A formal system by which qualified representatives of appropriate
disciplines review proposed or actual changes that might affect the registration and
validated status. The intent is to determine the need for action that would ensure that the
system is maintained in a regulatory compliant and validated state.
➢ confirmation testing. An execution of tests that confirm and validate the results obtained
by another.
➢ control strategy. A planned set of controls, derived from current product and process
understanding that assures process performance and product quality. The controls can
include parameters and attributes related to active pharmaceutical ingredient (API) and
finished pharmaceutical product (FPP) materials and components, facility and equipment

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 operating conditions, in-process controls, finished product specifications and the
associated methods and frequency of monitoring and control.
➢ corrective action. Any action to be taken when the results of monitoring at a critical control
point indicate a loss of control.
➢ critical. Having the potential to impact on product quality or performance in a significant
way.
➢ critical process parameter (CPP). A process parameter whose variability has an impact
on a critical quality attribute and therefore should be monitored and/or controlled to ensure
the process produces the desired quality.
➢ critical quality attribute (CQA). A physical, chemical, biological or microbiological
property or characteristic that should be within an appropriate limit, range or distribution
to ensure the desired product quality.
➢ design space. The multidimensional combination and interaction of input variables (e.g.
material attributes) and process parameters that have been demonstrated to provide
assurance of quality.
➢ drug master file. Detailed information concerning a specific facility, process, packaging
material or product submitted to the medicines regulatory authority, intended for
incorporation into the application for marketing authorization.
➢ finished pharmaceutical product (FPP). A product that has undergone all stages of
production, including packaging in its final container and labelling. An FPP may contain
one or more active
➢ pharmaceutical ingredients (APIs). In some cases, it may be in combination with a
medical device.
➢ gap analysis. The identification of the critical elements of a process which are available at
the sending unit (SU) but are missing from the receiving unit (RU) with the objective to
assess which gaps have potential impact on the process or method and to mitigate those
gaps, as appropriate.
➢ good manufacturing practices (GMP). That part of quality assurance which ensures that
pharmaceutical products are consistently produced and controlled to the quality standards
appropriate to their intended use and as required by the marketing authorization.
➢ technology transfer protocol (master plan). A document that describes the intended
sequential phases and activities of the transfer, and serves as a plan for the execution and
management of the transfer.
➢ technology transfer report. A documented summary of a specific technology transfer
project listing procedures, acceptance criteria, results achieved and conclusions.
➢ validation. Action of proving and documenting that any process, procedure or method
actually and consistently leads to the expected results
various guidelines are there ,these are the some guidelines about technology transfer protocol.

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Facts of technology transfer
The transfer of technology could happen in any of following ways
1. Government labs to private sector firms.
2. Between private sectors firms of same countries.
3. Between private sector firms to different countries.
4. From Academia to private sectors firms.
5. Academia, Government and industries collaborations.

Constituents of technology transfer

people
paper work
acceptance

publicity pricing

partnership

Various sectors involving technology transfer

• Technology transfer from R&D to actual manufacturing.
• Transfer technology of existing product between various manufacturing places.
• Technology transfer through R&D and production of drug related to post marketing
changes in manufacturing places.

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 Risk assessment

Classification Definition example

Critical Changes that directly affect the quality, - Product composition

safety and/or efficacy of the product changes;
and/or the reproducibility of the product.
- Equipment changes with
direct impact in the
manufacturing process;

Major Changes with a level of uncertainty or for - New batch size addition;
which impact level cannot be estimated.
- Changes to approved
analytical methods;

Minor Changes without impact in the quality - Label size change; -

product. Similar component
changes
- with identical
characteristics;

Conclusion
• Technology transfer is essential Factor for development of drugs or manufacture of new
drugs. Nowadays pharmaceutical industry is increasing rapidly for better research,
development and production technology transfer is important factor.
• Technology transfer can done by intra or inter in different country, or can be done by
various pharmaceutical industry in same country.
• Technology transfer must be done after proper research, clinical and preclinical trials,
record of equipment use and their SOP, and documentation of problems facing for
producing product.
• Technology transfer can done under guidance set by WHO or guidelines for overcome risk
factors, Technology transfer done by proper documentation, for technology transfer require
expertise or experienced persons.

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 Reference
1. The theory and practice of Industrial Pharmacy by Liberman & Lachman 3rd Edition.
2. International Society for Pharmaceutical Engineering. (2003). Technology Transfer. ISPE.
USA.
3. International Society for Pharmaceutical Engineering. (2003). Technology Transfer. ISPE.
USA.
4. Singh, A., Aggarwal, G. (2010). Technology Transfer in Pharmaceutical Industry: a
Discussion. International Journal of Pharma and Bio Sciences. 1: 15-23.
5. Lieberman, H., Lachaman, L. (2010). Teoria e Prática na Indústria Farmacêutica. Vol. 2. 2
nd . Foundation Calouste Gulbenkian. Lisbon.

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