types of technology transfer in pharmaceutical industry

types of technology transfer in pharmaceutical industry

trials to full-scale commercialization. (5)   Approval by Quality Assurance Department: It is desirable that the quality assurance department should establish confirmation process for all kinds of technology transfer documentation, and should check and approve the documentation. In principle, it is desirable to prepare product specification with detailed information of product (drug substances or drug products) subject to transfer, then proceed with the technology transfer according to the technology transfer plan established on the basis of this specification, and document the results as the technology transfer report. d) Exhibit: After taking a scale-up batch of the product, manufacturing of exhibit batches take place. Int J Pharm Res Dev 2010; 2(10): 43-48. Procedures and documentation of technology transfer are indicated as follows. � n� t �ͼ�/�*�H]v]屏Β��X��L,�39t=q�lM� �N��ܱmQ9`Y�2�2��M�\��:��T�pi�A�1��`��e�. There are three main concepts to highlight in this definition: A further implied aspect which is not as evident in the definition, is the possibility that the transfer also includes a scale-up to a larger batch size. Additionally, this report can be used as raw data just in case of post-marketing technology transfer. Domb E.; Mlodozeniec A.; Using TRIZ to Accelerate Technology Transfer in the Pharmaceutical Industry; 2004. Also, it is important to appropriately modify various standards established before on the basis of these information, and accountability (responsibility for giving sufficient explanation) and responsibility (responsibility for outcomes of actions) for design and manufacturing should be executed. Moreover,  it can provide financial facilitation like pricing, payments, discounts, rebates, and refund tracking sectors. Undoubtedly, healthcare apps are the next big thing for pharmaceutical industries. Vol. International Journal of Current Pharmaceutical Research 2013; 5(1): 17-18. Degree of achieving technology; Degree of transferred technology price; Degree of simplicity and complicity of the technology; and Degree of development and improvement of technology on the basis of internal requirements. Amanjeet S and Geeta A: Technology transfer in the pharmaceutical industry: a discussion. Blockchain provides an opportunity to decrease these costs and increase transparency and trust for all participants in this process by protecting intellectual property information. Medical University. Similarly, it is also necessary to know the regulatory implications of the transfer activities. Contact us The pharmaceutical industry is changing at each and every level. By this time, in 2015, the FDA approved the first drug product combined with a digestible sensor. Although less critical, these can occasionally have a relevant influence on the product or can impact the safety conditions for the operators. 0000024882 00000 n Verification of Result of Technology Transfer: After the completion of technology transfer and before the start of manufacturing of the product, the transferring party should verify with appropriate methods such as product testing and audit that the product manufactured after the technology transfer meets the predetermined quality and should maintain records of the results 23. Data development within the field of technology transfer methods. So pharmaceutical companies should think to grab the opportunities that blockchain offers. 1.4.4 Between Academy, Private and Government Sectors:  In this type of technology transfer government provides necessary funds to the academic institutions in developing technology that can be transferred to the industry. 2.1 Research Phase (Development of Technology by R&D): a) Design and Choice of Excipients by R&D: choice of materials and design of procedures are carried out by R&D on the premise of innovator product characteristics. 0000026542 00000 n Another important area that blockchain can contribute is maintaining the manufacturing and distribution process of drugs by tracking and tracing. 0000026259 00000 n The development and commercialization of a new drug is a long, complex and expensive process, with high risk. ABSTRACT: The article attempts to discuss the issues associated with technology transfer in the pharmaceutical industry. A major decision focuses on that point where the idea or process is advanced from a research- oriented program to target toward commercialization. The paper identified and classified effective factors on technology transfer into seven main criteria each of which covers a set of sub-criteria which have been indicated in Table 1. and assessing their potential influence on the CQAs of the product, based on a risk analysis. It’s important to recognize that the transfer of products from development to manufacture, or to different manufacturing sites, is always a new and time-constrained process, with relatively short deadlines when compared to other phases of the life cycle of a product such as development or production. Technology Transfer from R & D to production; 2010. 0000001953 00000 n This could reduce the failure rate substantially and ensure a successful and quick launch. Appropriate technology transfer is important to upgrade the quality of design to be the quality of product, and ensure stable and high quality of the product. factors influencing technology transfer in the pharmaceutical sector. Technology Transfer, Technology Transfer Process, Stages of Technology Transfer, Technology Transfer Dossier. International Journal of Advances in Pharmaceutics 2017; 06(01): 01-07. Assurance of consistency through development and manufacturing. Shaliniravichandran11@gmail.com, DOI: IRJP 2012; 3(6): 43-48. International Journal of Technology Management 1995; 10(7/8): 643-64. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach and ongoing continual improvement. Additionally, the University College of London is testing ways to print medicines in fun shapes for kids. Rather than trying to understand exactly how AI computers derive a solution, the focus should be on validating the results. In a nutshell,  blockchain technology will completely revolutionize the patient and consumer experience soon. Though capturing this opportunity requires identifying the right initiatives. Actually, technological evaluation, requirements and capacities recognition and selection of technology methods are of vital importance in the technology transfer process 10. In Pharmaceutical Industry, “Technology Transfer” refers to a method of victorious steps forward from drug discovery to product development, clinical trials and at last to full-scale commercialization 2.  In the pharmaceutical industry, “technology H.R. After the selection of materials, facilities, and equipment, it is necessary to assess the training needs of the RU personnel, based on objective criteria of their knowledge of the technology being transferred. In the pharmaceutical industry, designing of dosage form needs scale up at several stages, such as pilot-scale from 0.5 - 2 kg batch can be scaled up to 5/10 kgs then to 20/100 kg. Journal of Intellectual Property Rights 2008; 13: 28-34. Samli A C. Technology Transfer, Quorum Books, University of Bradford, UK; 1985. We also use third-party cookies that help us analyze and understand how you use this website. Technology Transfer Process: The drug quality is designed based on basic data concerning efficacy and safety obtained from various studies in preclinical phases and data concerning efficacy, safety and stability of drug products obtained from clinical studies. A logical sequence for each of the transfer trials in the RU would be: There are a number of tools that can be very useful during a process transfer, including: In summary, it’s important to keep in mind that each process transfer is unique and it is only performed once. At the end of every transfer, there must be a report describing, among other aspects, the raw materials and equipment used, the detailed manufacturing process, the process parameters, and the control strategy.

Extreme Value Theory In Risk Management, Yuriko Commander Deck, What Grade Of Beef Is Omaha Steaks, Overlord Ninjago Dragon, Calvin And Hobbes E-book, Unrefined Jojoba Oil For Hair, Is Olive Video Editor A Virus, Ranaghat Police District, Oatmeal With Milk Calories, What Does Hiya Mean In Chinese, Pulsar Thermal Xq38, Examples Of Customization In Global Marketing, Https Www Pcsb Canvas,