Technical Information Magazine 202303-03 GMP System
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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