We shall examine some tools and strategies that can be used in representing, communicating and exchanging project and process information throughout the different. 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. Jul 15, 2014 technology transfer is both integral and critical to drug discovery and development for new medicinal products. Apr 23, 2015 technology transfer is a mature process in the pharmaceutical industry. Who guidelines on transfer of technology in pharmaceutical manufacturing 1. Technology transfer, scale up, exhibit, pharmaceutical production. Modelling technology transfer as a process strategy 303 fig. The anatomy of technology transfer in the pharmaceutical sector. Moreover, the researchbased pharmaceutical industry strives to ensure that the transfer of technology also reflects its commitment to global health. 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.
Sop on transfer of technology for manufacturing process. Technology transfer of medicines and vaccines shares many of the challenges of other advanced industries. 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. Technology transfer, manufacturing, steps involved, research and development.
Key considerations for successful technology transfers. Technology transfer and pharmaceutical quality systems fda. In pharmaceutical industry, technology transfer refers to a method of victorious steps forward from drug discovery to. A best practice approach defining technology transfer. Practical application of technology transfer t19 overview. 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. Pharmaceutical production and related technology transfer. Efficient technology transfer through a collaborative plm. Technology transfer in pharmaceutical manufacturing impact factor. Technology transfer is important for such researcher to materialize on a larger scale for.
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. Appropriate technology transfer is both vital and critical to drug discovery and development for novel medicinal products and is also essential to. A continuous improvement of regulatory and quality frameworks is only one of many reasons. Conclusionin pharmaceutical industry, technology transfer means action to transfer of information and technologies necessary to realize quality of design of drugs during manufacturing. Its success is contingent upon detailed and reliable communication, planning, discipline and documentation. Technology transfer projects for local production 65 annex ii.
Overcoming the tech transfer challenge contract pharma. The technology transfer planning template ttpt is an online planning tool for creating technology transfer and commercialization plans. The key aspects during departmental technology transfer diva portal. 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. Inventors and project investigators who are developing inventions that may have market potential can benefit from the templates intuitive. According to the actualized gmp rules, the technology transfer is an essential part of pharmaceutical quality system at a modern pharmaceutical company. 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. The technology transfer in pharma and biotech course will be illustrated with many real examples. Technology transfer sop of drug product pharma beginners. Apr 10, 2017 the technology transfer stage is a critical one to get correct.
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. 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. The report includes practical examples of technology transfer activities. For a typical researchbased pharmaceutical company, drug discovery and development can be broken down into distinct. Dhhsfda, pharmaceutical cgmps for the 21st century a. 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. However the authors think that the suggested technology transfer model, needs further development in details. Technology transfer embodies both the transfer of documentation and the. 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. This article describes the documentation steps required for performing a successful solid oral dosage technology transfer. Process development early the technology transfer process ideally starts early during the process development life cycle.
Technology transfer pharmaceutical training courses. 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. Apr 17, 2017 american journal of pharmaceutical research. We have been leading several transfers for large, small and mos within pharma organizations, covering process and. 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. Nov 10, 2016 the technology transfer process has been simplified into four stages described in more detail below. Pharmaceutical companies require a new product every three to five years in order to sustain growth.
Technology transfer and pharmaceutical quality systems. 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. Frequently, it is necessary to transfer a technology from a developing site to a. 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. For your convenience, each step in the ntk model is listed, along with the corresponding ttpt questions and your responses. Technology transfer in pharmaceutical contract manufacturing. 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. In recent years, the researchbased pharmaceutical industry has pushed forward with this unique type of technology transfer. Technology transfer is very common in pharmaceutical manufacturing but is often taken for granted, which can lead to production problems and increased costs.
The objective is to transfer expertise, technical information e. 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. Pqs principles, gmp includes every stage of drug life cycle, starting from its pharmaceutical development, technology transfer, commercial manufacturing and. Manufacturing process transfers in the pharmaceutical. Technology transfer pharmaceutical training courses, pharma. Mar 14, 2017 manufacturing process transfers in the pharmaceutical industry. Technology transfer as the process of pharmaceutical quality system. Developing effective protocols for technology transfer is essential for addressing current industry challenges and evolving business needs. Technology transfer plays a vital role in the process of drug discovery to the product development and the full scale commercialization. Pdf technology transfer in pharmaceutical industry. 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.
Process technology transfer step track record and facts this is a summary of our main technology transfer experience. The recent gmp good medical practice rules actualisation and its requirements introduction widened the gmp guidelines for every life cycle of medicinal. Technology transfer as the process of pharmaceutical quality. Modern technology transfer strategies for biopharmaceutical.
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. Licensing is one such aspect of technology transfer which is gaining prominence among pharmaceutical companies. Each organization should adopt a policy or procedure to manage transfers of technology in a structured and consistent way. Technology transfer in pharmaceutical industry the pharma. Pdf technology transfer as the process of pharmaceutical quality. One of the most important aspects in pharmaceutical industries is the manufacturing process. Introductiontechnology transfer, also called transfer of technology tot, is the process of transferring skills, knowledge, technologies, methods of. The advances in software technology have provided the opportunity to develop customized tools to address specific needs of technology transfer in bio pharmaceutical manufacturing. Pharmaceutical technology transfer training course. Factors that have facilitated international technology transfer include. Pharmaceutical guidelines guideline for technology transfer 1. 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.
The report provides an overview of the knowledge and skills used during a successful technology. 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. The three primary considerations to be addressed during an effective technology transfer are the plan, the persons involved, and the process. Ich guideline q10 on pharmaceutical quality system step 5. In pharmaceutical industry, technology transfer refers to the processes of successful progress from drug discovery to product development, clinical trials and ultimately fullscale commercialization. European journal of pharmaceutical and medical research. Technology transfer is, however, not present in every step of the. Technology transfer in the pharmaceutical industry refers to the processes of. Best practices can be incorporated into early stage development phase i long before facility selection. We have been leading several transfers for large, small and mos within pharma organizations, covering process and analytical methods transfers. 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. Outlines all transfer activities and responsibilities in great detail. Medicine, life cycle, technology transfer, process scaling, pharmaceutical quality system, quality system procedures. Technology transfer as the process of pharmaceutical.
A guidebook on preparing technology transfer projects for. Technology transfer, ich guidelines, regulatory aspects cite this article as. It aims to devise sustainable ways not only of bridging researchandde. Planning for successful technology transfer anthony grenier. Guidance for industry q10 pharmaceutical quality system. The aim of the thesis is to contribute to the knowledge about correct validation of processes and successful technology transfers. Introduction the modern quality assurance system for medicinal. 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. Managing technology transfer projects in pharma in the dynamic world of pharma significant changes need to be handled on a daily basis. Annex 7 who guidelines on transfer of technology in. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach and ongoing continual improvement.
In pharmaceutical industry, technology transfer refers to a method of victorious. Department of health and human services food and drug administration center for drug evaluation and research cder. It occurs through many channels, all of which result in improving the economic capabilities of the recipient. The article highlights the objective, reasons for undergoing technology transfer, factors which affect technology transfer, steps involved in technology transfer process.
As the industry continues to experience changes, technology transfer for active pharmaceutical ingredients apis, finished dosage forms and analytical methods between development and. Technology transfer issues in licensing pharmaceutical products. Phrma quality technical committee, 2003 robustness is the ability of a process to demonstrate acceptable quality and performance, while. It is also required to upgrade drug quality planned during research development and to final product during manufacturing as well as to. 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. As the industry continues to experience changes, technology transfer for active pharmaceutical ingredients apis, finished dosage forms and.
1089 857 417 59 799 1555 188 100 928 1555 389 1196 1310 1374 1252 909 378 932 1605 1334 1543 11 7 1144 1493 1447 312 217 1250 771 1596 1473 1765 1040 72