The R&D department should clarify considerations of GMP compliance specific to subject drugs and manufacturing methods (manufacturing processes), and present them to a facility and equipment department. Another important area that blockchain can contribute is maintaining the manufacturing and distribution process of drugs by tracking and tracing. The Japanese pharmaceutical organizations Otsuka and Proteus Digital Health combined a digestible sensor with a type of drug against mental illness. Authors Address: Both parties should cooperate in implementing technology education training and validation at facilities where the transferred technology is actually used. This creates a particular challenge for R&D pharmaceutical technology transfer and means that those parts of the world least equipped to benefit today from technology transfer are among those who need its products the most. The ultimate goal for successful technology transfer is to possess documented evidence. On the other hand, the technical team of the RU has knowledge of the available technologies and equipment at the receiving manufacturing plant. Defining Technology Transfer 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 professional expertise between development and manufacture or between manufacture sites.” 1 The purpose of the documentation is to prove that, despite the change of manufacturer, the drug product will continue to meet the quality, safety, and efficacy requirements that allowed it to receive the MA. On the one hand, the technical team of the SU, which has the knowledge of the product and process to be transferred (critical steps, critical quality attributes—CQAs—and critical process parameters—CPPs, etc.). 0000015187 00000 n Pharma executives as well as researchers, innovators, and lawmakers are well aware of the disruptive potential and are experimenting with a wide range of digital initiatives. Researcher of technology creates his technology existing to a commercial collaborator which will make use of the technology. There are 3 standards in the definition of technology: There are two sorts of technology transfer processes 7: Vertical technology transfer refers to the transfer of data from basic study to development and production respectively. 1: REPRESENTATION OF TECHNOLOGY TRANSFER. A government’s willingness to create optimal conditions to attract technology is a strong determinant of whether transfers will be directed towards their domestic industrial sector. It’s important to remember that during a manufacturing process transfer there is a quantitative-qualitative formulation, a defined manufacturing process and previously defined CQAs for the finished product that cannot be modified. Forty-third report. Research-based 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 However, it is recommended to check if they comply with current regulatory requirements at the time of the transfer. Alam MS and Ahmad J: Pharmaceutical Technology Transfer: An Overview. The technology transfer does not mean one time actions taken by the transferring party toward the transferred party, but means continuous information exchange between the both parties to maintain the product manufacturing. The most effective role for governments is one of creating optimal enabling conditions, linked to the country’s overall economic policy objectives. Many of these are influenced by government policy decisions. In turn, this should theoretically improve the drug development success rate and streamline R&D efforts. for their research work, and the technology developed by them reaches the private sector. It’s essential to contemplate the production surroundings and system throughout the development of the method. A major decision focuses on that point where the idea or process is advanced from a research- oriented program to target toward commercialization. The development report contains the following: b) Technology Transfer Plan: The technology transfer plan describes the things and contents of technology to be transferred and elaborate procedures of individual transfer and transfer schedule, and to determine judgment criteria for the completion of the transfer. International Journal of Pharma and Bio Sciences 2010; 1(3):1-3. Organizational, equipmental and informational infrastructures. methods of manufacturing, samples of To assure the drug quality, it is desire to make sure that is what, when, and why information should be transferred to where and by whom and how to transfer, then share knowledge and information of the technology transfer each other between stake holders related to drug manufacturing. The raw data of the documents (such as development report) should be prepared and compiled according to purposes, and should be always readily available and traceable. 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. Silvestri. It is useful to build up dosage form in various ways because it provides efficiency in development, maintains quality of product, helps to realize a standardized process that facilitates price-effective production 5. Jiang Guorui. The International Pharmacopoeia, 4th ed. Mohite PB and Sangle SV: Technology transfer in the pharmaceutical industry- a review. UNCTAD 2002. Pharmaceutical and vaccine manufacturers consider a variety of factors in evaluating potential technology transfer ventures. 0000035523 00000 n Now customize the name of a clipboard to store your clips. Though capturing this opportunity requires identifying the right initiatives. manufacturing and facilities among World Journal of Pharmaceutical Research 2017; 6(9): 310-29. The Anatomy of Technology Transfer in the Pharmaceutical Sector: It’s much more than simply handing over technology: The transfer of R&D pharmaceuticals is providing a “tool box”. 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. The following items are part of dossier. Patil RP: Technology Transfer in Pharmaceutical Industry: objectives, Issues & Policy Approaches. Competitiveness Review 1999; 9(1): 9-1. IoT has incredible potential to help the pharmaceutical industry. Int J Pharm Res Dev 2010; 2(10): 43-48. The processes are classified broadly into the following five categories. The transferring party ought to prepare the plan before the implementation of the transfer and reach an agreement on its contents with the transferred party. Department of Pharmacy Practice, KMCH College of Pharmacy, Coimbatore, Tamil Nadu, India. Email: For this kind of documentation management and information updating, it is desirable to establish product specification describing entire characteristics of the product in addition to the development report, which is to be revised and updated regularly. Gupta, Surbhi S and Seema: Technology transfer in the pharmaceutical industry - an overview. The transfer may be said to be successful if the receiving unit and the transferee can effectively utilize the technology for business gain. Technological Forecasting and Social Change 1987; 32: 19-35. 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. Besides, mobile apps that will connect patients with health insurance companies can eliminate the long process of document authentication and other verification activities. The real changes in the company's work can be introduced by transfer of knowledge, skills, and intellectual property rights. The Right Conditions for Pharmaceutical Technical Transfer- Commercial opportunities are paramount for the private sector when considering technology transfer, but if the basic conditions are right, non-commercial reasons may also play a part. organizations. In order to ensure the authorized therapeutic effect, the product must meet the quality specifications, remain stable, and its bioavailability must be equivalent. Effective technology transfer helps to provide process efficiency and maintain product quality.


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