Moreover, the researchbased pharmaceutical industry strives to ensure that the transfer of technology also reflects its commitment to global health. Technology transfer and pharmaceutical quality systems fda. Medicine, life cycle, technology transfer, process scaling, pharmaceutical quality system, quality system procedures. Overcoming the tech transfer challenge contract pharma. Aug 17, 2017 technology transfer team shall coordinate for the collection of all relevant documents and shall prepare or complete the checklist as per annexure no i. It aims to devise sustainable ways not only of bridging researchandde. Technology transfer pharmaceutical training courses. Technology transfer sop of drug product pharma beginners. Technology transfer in pharmaceutical contract manufacturing. Jul 15, 2014 technology transfer is both integral and critical to drug discovery and development for new medicinal products. The technology transfer planning template ttpt is an online planning tool for creating technology transfer and commercialization plans. For your convenience, each step in the ntk model is listed, along with the corresponding ttpt questions and your responses. According to the actualized gmp rules, the technology transfer is an essential part of pharmaceutical quality system at a modern pharmaceutical company. Technology transfer in pharmaceutical manufacturing impact factor.
The report includes practical examples of technology transfer activities. Identify and mitigate risks in technology transfer processes understand main roles and responsibilities of the stakeholders of technology transfer process manage project changes managing technology transfer projects in pharma in the dynamic world of pharma significant changes need to be handled on a daily basis. Modern technology transfer strategies for biopharmaceutical. While some aspects of the pharmaceutical quality system can be companywide and others sitespecific, the effectiveness of the pharmaceutical quality system is normally demonstrated at the site level. Technology transfer of medicines and vaccines shares many of the challenges of other advanced industries. We have been leading several transfers for large, small and mos within pharma organizations, covering process and analytical methods transfers. The report provides an overview of the knowledge and skills used during a successful technology. Efficient technology transfer in pharmaceutical industry through a plmbased collaborative platform abstract pharmaceutical drug development is an extremely long and arduous process involving high technology transfer costs. To summarize the essence of site transfer processes from the prospect to the cmo, it is imperative to note that technology transfer is not a random process. Technology transfer issues in licensing pharmaceutical products.
Apr 17, 2017 american journal of pharmaceutical research. The recent gmp good medical practice rules actualisation and its requirements introduction widened the gmp guidelines for every life cycle of medicinal. The body of knowledge available for a specific product and process, including criticaltoquality product attributes and process parameters, process capability, manufacturing and process control technologies and quality systems infrastructure. Sop on transfer of technology for manufacturing process. Appropriate technology transfer is both vital and critical to drug discovery and development for novel medicinal products and is also essential to. Managing technology transfer projects in pharma in the dynamic world of pharma significant changes need to be handled on a daily basis. In pharmaceutical industry, technology transfer refers to a method of victorious. Pqs principles, gmp includes every stage of drug life cycle, starting from its pharmaceutical development, technology transfer, commercial manufacturing and. Technology transfer projects for local production 65 annex ii. Best practices can be incorporated into early stage development phase i long before facility selection. The article highlights the objective, reasons for undergoing technology transfer, factors which affect technology transfer, steps involved in technology transfer process. Pdf technology transfer as the process of pharmaceutical quality.
In the pharmaceutical industry, technology transfer refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials to fullscale commercialization or it is the process by which a developer of technology makes its technology available to commercial partner that will exploit the. Department of health and human services food and drug administration center for drug evaluation and research cder. Who guidelines on transfer of technology in pharmaceutical manufacturing 1. Key considerations for successful technology transfers. According to annex 7 of the world health organization who guidelines on the transfer of technology in pharmaceutical manufacturing, technology transfer is defined as a logical procedure that controls the transfer of any process together with its documentation and.
Technology transfer as the process of pharmaceutical quality system. Process technology transfer step track record and facts this is a summary of our main technology transfer experience. The pharmaceutical technology transfer activities are to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product. We have been leading several transfers for large, small and mos within pharma organizations, covering process and. Technology transfer is, however, not present in every step of the. The objective is to transfer expertise, technical information e. Technology transfer as the process of pharmaceutical. Frequently, it is necessary to transfer a technology from a developing site to a. Developing effective protocols for technology transfer is essential for addressing current industry challenges and evolving business needs. As the industry continues to experience changes, technology transfer for active pharmaceutical ingredients apis, finished dosage forms and analytical methods between development and. Each organization should adopt a policy or procedure to manage transfers of technology in a structured and consistent way. Technology transfer plays a vital role in the process of drug discovery to the product development and the full scale commercialization. In recent years, the researchbased pharmaceutical industry has pushed forward with this unique type of technology transfer. Pharmaceutical guidelines guideline for technology transfer 1.
However the authors think that the suggested technology transfer model, needs further development in details. Technology transfer and pharmaceutical quality systems. Pharmaceutical production and related technology transfer. Ich guideline q10 on pharmaceutical quality system step 5. Process development early the technology transfer process ideally starts early during the process development life cycle. In the pharmaceutical industry, technology transfer refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials to fullscale commercialization or it is the process by which a developer of technology makes its technology available to commercial partner that will exploit the technology. Pharmaceutical technology transfer training course. The key aspects during departmental technology transfer diva portal. The technology transfer in pharma and biotech course will be illustrated with many real examples. European journal of pharmaceutical and medical research.
Introductiontechnology transfer, also called transfer of technology tot, is the process of transferring skills, knowledge, technologies, methods of. Aside from the science itself and manufacturing capabilities and scientific expertise, tech transfer, like documentation in the api manufacturing process, is an importantbutoftenoverlooked component to the success of any project. Pharmaceutical companies require a new product every three to five years in order to sustain growth. Modelling technology transfer as a process strategy 303 fig. A technology transfer plan which often takes the form of a gantt chart, as in figure 5 should include the sequence of all transfer activities. A guidebook on preparing technology transfer projects for. The three primary considerations to be addressed during an effective technology transfer are the plan, the persons involved, and the process. Technology transfer as the process of pharmaceutical quality. Technology transfer in the pharmaceutical industry refers to the processes of. Nov 10, 2016 the technology transfer process has been simplified into four stages described in more detail below.
We shall examine some tools and strategies that can be used in representing, communicating and exchanging project and process information throughout the different. As the industry continues to experience changes, technology transfer for active pharmaceutical ingredients apis, finished dosage forms and. It is also required to upgrade drug quality planned during research development and to final product during manufacturing as well as to. The pharmaceutical technology transfer activities are to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realisation.
Technology transfer in pharmaceutical industry remya mariam john abstract in todays business setting, interest in the profitable exploitation of a firms technological assets, through technology transfer, has intensified. The aim of the thesis is to contribute to the knowledge about correct validation of processes and successful technology transfers. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach and ongoing continual improvement. Licensing is one such aspect of technology transfer which is gaining prominence among pharmaceutical companies. For a typical researchbased pharmaceutical company, drug discovery and development can be broken down into distinct. Mar 14, 2017 manufacturing process transfers in the pharmaceutical industry. Apr 23, 2015 technology transfer is a mature process in the pharmaceutical industry. Technology transfer is important for such researcher to materialize on a larger scale for. The anatomy of technology transfer in the pharmaceutical sector. 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. Factors that have facilitated international technology transfer include. Apr 10, 2017 the technology transfer stage is a critical one to get correct.
Introduction the modern quality assurance system for medicinal. Technology transfer, scale up, exhibit, pharmaceutical production. Manufacturing process transfers in the pharmaceutical. Dec 18, 2019 technology transfer product transfer is a complete documented process that covers the detailed documentation for manufacturing and dispatch of the first batch, received from the parent location or fdd of a new or existing product from a particular site with manufacturing, packaging and analytical details.
Technology transfer and the drug discovery and development process technology transfer is both integral and critical to the drug discovery and development process for new medicinal products. Understand cqas and cpps to enable a control strategy to be developed provide sufficient details of controls to enable technology transfer pharmaceutical development technology transfer pharmaceutical development technology transfer manufacturing execute in a state of. A best practice approach defining technology transfer. Outlines all transfer activities and responsibilities in great detail. Conclusionin pharmaceutical industry, technology transfer means action to transfer of information and technologies necessary to realize quality of design of drugs during manufacturing. The advances in software technology have provided the opportunity to develop customized tools to address specific needs of technology transfer in bio pharmaceutical manufacturing. It occurs through many channels, all of which result in improving the economic capabilities of the recipient. This article describes the documentation steps required for performing a successful solid oral dosage technology transfer. Practical application of technology transfer t19 overview. The workshops in montreal and bonn, organized in collaboration with the climate technology initiative cti and the private sector, both highlighted the need for toolkits and handbooks on innovative and noninnovative financing of technology transfer projects to improve project preparation and assessment to international standards. Annex 7 who guidelines on transfer of technology in.
Technology transfer plan abbreviated version this output report matches the need to knowledge models steps to your ttpt responses to form a comprehensive technology transfer plan. Technology transfer embodies both the transfer of documentation and the. Technology transfer, manufacturing, steps involved, research and development. A continuous improvement of regulatory and quality frameworks is only one of many reasons. Technology transfer in pharmaceutical industry the pharma. Technology transfer pharmaceutical training courses, pharma.
The contents of the technology transfer planning template, and this document were developed under a grant from the national institute on disability, independent living, and rehabilitation research, nidilrr grant number 90dp00540100. Technology transfer team shall coordinate for the receipt of comments from all relevant department involved in technology transfer as mentioned in the proposal as per annexure no. Planning for successful technology transfer anthony grenier. In pharmaceutical industry, technology transfer refers to a method of victorious steps forward from drug discovery to. Researchbased pharmaceutical industry programs provide insights for policy makers as technology transfer is poorly captured in official statistics, this booklet seeks to inform the policy discussions by providing an overview of recent technology. Inventors and project investigators who are developing inventions that may have market potential can benefit from the templates intuitive. One of the most important aspects in pharmaceutical industries is the manufacturing process. Phrma quality technical committee, 2003 robustness is the ability of a process to demonstrate acceptable quality and performance, while. In pharmaceutical industry, technology transfer refers to the processes of successful progress from drug discovery to product development, clinical trials and ultimately fullscale commercialization. Its success is contingent upon detailed and reliable communication, planning, discipline and documentation.
Technology transfer, ich guidelines, regulatory aspects cite this article as. Efficient technology transfer through a collaborative plm. Entities majority of companies do not have license agreements with federal government half of the companies were founded on the basis of a license agreement. Pdf technology transfer in pharmaceutical industry. Technology transfer is very common in pharmaceutical manufacturing but is often taken for granted, which can lead to production problems and increased costs.
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