AI checks the huge number of approvals, standards, and instructions for discrepancies and discrepancies. It simplifies the process of checking texts line by line and discovering discrepancies and parent languages.

In the past, discrepancies between manufacturing and sales approvals and the actual manufacturing conditions at manufacturing plants have been confirmed in the pharmaceutical industry. As a result, the Ministry of Health, Labor and Welfare issued an order in April this year to "conduct inspections related to the consistency between manufacturing and sales approvals for generic drugs and the actual manufacturing and testing methods," and there is an even greater demand for strengthened compliance in GQP operations in the manufacturing and sales industry. In addition, the supply in the domestic labor market is becoming short, and it is becoming more difficult to secure sufficient time and human resources for quality assurance operations. In order to solve these issues, we have developed a manufacturing and sales approval checker service that uses AI to streamline document matching and inspection operations. This document introduces the details of the "Macnica Manufacturing and Sales Approval Checker."

Transforming discrepancy checks with 'Manufacturing and Sales Approval Checker,' an AI-powered tool supporting strict adherence to approval documents.
The discrepancy between manufacturing approval documents and actual manufacturing practices is considered a contributing factor to concerns about the supply of pharmaceuticals. From the perspective of ensuring compliance with approval requirements, which are a prerequisite for guaranteeing quality and reliability, the government is demanding thorough investigations, and Macnica. In this article, we explore the background of the "approval document discrepancy problem" and interviewed Hirofumi Hayashi and Daisuke Hatakeyama of the Quality Assurance Division, Quality Assurance Department, KM Bio, about the possibilities of using AI to solve it.