Pharmaceutical Product Manufacturing Readiness Levels

Le résumé fourni par la source

With a high level of fundamental research, there is a gap between fundamental and applied research, and there is a discrepancy between the proposed research results and possible integration into industrial production cycles. Within the life cycle of a pharmaceutical product, reliable processes are the foundation for the successful operation of the enterprise. The duration of development of pharmaceutical products and projects for their implementation require the involvement of significant resources and are associated with significant risks. Starting from the earliest stages of project implementation, it is advisable to use universal, fairly simple indicators and metrics that do not depend on the type of technology and systems being developed, which allow for an adequate assessment of their current development. The production readiness level is a unified parameter used as a tool for assessing how close the results of the project’s technology readiness are to market expectations. It includes measuring the maturity of the technologies/product being developed and will allow you to quickly assess the “maturity” of the selected portfolio, assess the current and desired future of the project, improve the quality of planning, implementation and sustainability of the project.

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