This method is called the “silico trial”. Procedures and documentation of technology transfer are indicated as follows. 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. Your email address will not be published. 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 full-scale commercialization 2. Once 3D printing was just a concept of sci-fi fantasies. Production scale typically ranges from 200 kg to 1000 kg. Kaur A, Sharma OP and Dhari J: Technology transfer in pharmaceutical industry S. Shalini *, K. Nijanthan, B. Rajkumar, S. Muthukumar, C. Sankar and G. Arulkumaran. q)       Responsible for analytical technique transfer for drug substance and drug product. Establishing integrated plans (key activities, dependencies, inputs/outputs, and deliverables) between the sending and receiving parties. 1. Biruk A and Biruk Abate: Technology transfer in pharmaceutical industries through product development and scale-up approaches: challenges and opportunities for developing countries. Consideration of existing and old technologies. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach and ongoing continual improvement 3. 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. Alam MS and Ahmad J: Pharmaceutical Technology Transfer: An Overview. Please accept cookies for optimal performance. 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. Basic Policies on the Establishment of the Guideline for the Technology Transfer. If you continue browsing the site, you agree to the use of cookies on this website. The The ultimate aim is to measure drug adherence in the treatment of adults with schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and as adjunctive therapy for the treatment of major depressive disorder in adults. TABLE 1: EFFECTIVE FACTORS IN TECHNOLOGY TRANSFER 11, 12. Also since product improvements and changes of specifications and methods are often implemented, the initial technical information should be reviewed and updated at regular intervals. Adopting cutting-edge technologies can play a vital role in the digital revolution of the pharmaceutical industry. The technology transfer team consists of the following members, and their responsibilities are given below: 20, TABLE 1: TECHNOLOGY TRANSFER TEAM MEMBERS AND THEIR RESPONSIBILITIES, b)       Collates documentation from the donor site. 0000035523 00000 n Pyle and L.J. With their ability to create a captivating virtual world with minute details, AR and VR are promising technologies that can cater to a wide range of needs of the pharmaceutical industry. There are other variable aspects that can be modified or adjusted at the tech transfer stage in order to obtain a product within specifications, such as the correct selection of equipment, the determination of process parameters and its control strategy. This knowledge forms the basis for the manufacturing process, control strategy process validation approach and ongoing continual improvement 9. H.R. Blockchain provides an opportunity to decrease these costs and increase transparency and trust for all participants in this process by protecting intellectual property information. The generic name, MFC number, page number, effective date, shelf life, and market. Nevertheless, to get to this point, there needs to be a change in the current R&D approaches. The article highlights the objective, reasons for undergoing technology transfer, factors which affect technology transfer, steps involved in technology transfer process. Various standards for manufacturing and tests will be established in process of reviewing factory production and Phase III study to realize the quality of design, and the quality of design will be verified in various validation studies, and will be upgraded to be the quality of product, and the actual production will be started. 8th floor, Plot#2, Amtoli, Bir Uttam AK Khandakar Rd Mohakhali Commercial Area, Dhaka-1212. FIG. It helps to track the results of cross-collaboration which leads to quicker breakthroughs and fast-track the overall process while saving time and money for all participants. The transfer is not the end goal per se, but the path to manufacture the pharmaceutical product in a different plant. It’s not that easy to determine what initiatives to take to scale up and how, as they are still blurry to visualize what digital success will look like in ten years from now. Using this technology, they then produced Spritam, which treats Epilepsy. Md. Anuj A and Bhuvnesh KS: A review on the importance of technology transfer in pharmaceutical industry. Also as in the case of technology transfer from research and development to production, responsibilities for the technology transfer should be clearly defined, documentation of technology transfer should be prepared, and the technology transfer should be implemented through adequate exchanges of technical information. The product specification file should be reviewed at regular intervals, and incorporate various informations obtained after the start of production of the product, and be revised as appropriate. We also use third-party cookies that help us analyze and understand how you use this website.  In the pharmaceutical industry, “technology Ivan Illich's work on education, medicine, and energy was a critique of the basic professionalism implicit in the TOT model ( 1992 ). 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. This website uses cookies in order to offer you the most relevant information. 1: REPRESENTATION OF TECHNOLOGY TRANSFER. Another important area that blockchain can contribute is maintaining the manufacturing and distribution process of drugs by tracking and tracing. The following exemplifies information to be contained in the development report. The ultimate goal for successful technology transfer is to have documented evidence that the manufacturing processes for drug substances and drug product, respectively, are robust and effective in producing the drug substances and drug product complying with the registered specifications and Good Manufacturing Practice requirements. 1.6 Flow Chart of Technology Transfer in the Pharmaceutical Industry: 1.8 Factors that Affect the Process if Technology Transfer in the Pharmaceutical Industry: Various Steps Concerned in Technology Transfer as Follows: 16, 17, 18. We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. (1)   Research and Development Report: The research and development report (development report) is a file of technical information necessary for drug manufacturing, which is obtained from pharmaceutical development, and the research and development department is in charge of its documentation.

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