We will introduce our efforts to address data integrity in response to the increasing inquiries from customers while conducting pharmaceutical analysis under the GMP system.
The technical information magazine The TRC News provides the latest information on analytical techniques that are useful for research and development, resolving production troubles, and quality control. **Abstract** In recent years, as the demand for data integrity (DI) in the pharmaceutical industry has increased, pharmaceutical companies and contract testing organizations are required to respond accordingly. The Toray Research Center's CMC Analytical Research Department (hereinafter referred to as CMC) conducts pharmaceutical analysis under a GMP framework as a contract testing organization. In response to the growing inquiries and requests regarding DI from various customers, we have launched a DI project to address these needs. This article introduces CMC's initiatives for DI compliance. **Table of Contents** 1. Recent developments regarding DI 2. Launch of the DI project 3. Initiatives related to equipment 4. Initiatives related to documentation 5. Conclusion
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Technical Information Magazine The TRC News "Efforts Towards Data Integrity in GMP Systems" [Abstract] In recent years, as the demand for data integrity (DI) in the pharmaceutical industry has increased, pharmaceutical companies and contract testing organizations are required to respond accordingly. At the Toray Research Center CMC Analysis Research Department (hereinafter referred to as CMC), we conduct pharmaceutical analysis operations under GMP systems as a contract testing organization. In response to the growing inquiries and requests regarding DI from various clients, we have launched a DI project to address these issues. This article introduces CMC's efforts towards DI compliance. [Table of Contents] 1. Recent Situation Regarding DI 2. Launching the DI Project 3. Initiatives Related to Equipment 4. Initiatives Related to Documentation 5. Conclusion [Figures] Figure 1 Measurement Equipment Prioritized for DI Compliance Figure 2 Overview of the Data Management System
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2,200 yen (including tax)
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P1
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Please see https://www.toray-research.co.jp/service/trcnews/.
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At Toray Research Center, Inc., we provide technical support through analytical techniques and physical property analysis to address various challenges in research and development as well as production fields via contract analysis. Based on our long-standing achievements and extensive experience in analysis and physical property evaluation, we continue to strive to meet the advanced and diverse needs of our customers.
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